FDA Approves Apellis鈥� EMPAVELI庐 (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older
Apellis Pharmaceuticals (Nasdaq: APLS) has received FDA approval for EMPAVELI庐 (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years and older.
The approval is based on the Phase 3 VALIANT study results showing three key achievements: a 68% reduction in proteinuria (p<0.0001), stabilization of kidney function (p=0.03), and substantial clearance of C3 deposits, with 71% of treated patients achieving complete clearance.
This breakthrough treatment targets rare kidney diseases affecting 5,000 people in the United States, where approximately 50% of patients progress to kidney failure within 5-10 years of diagnosis. The therapy demonstrated efficacy across both adolescent and adult patients, including those with post-transplant disease recurrence.
Apellis Pharmaceuticals (Nasdaq: APLS) ha ottenuto l'approvazione dalla FDA per EMPAVELI庐 (pegcetacoplan), il primo trattamento per la glomerulopatia C3 (C3G) e la glomerulonefrite membranoproliferativa da complessi immuni primari (IC-MPGN) in pazienti di et脿 pari o superiore a 12 anni.
L'approvazione si basa sui risultati dello studio di Fase 3 VALIANT, che ha evidenziato tre risultati chiave: una riduzione del 68% della proteinuria (p<0,0001), la stabilizzazione della funzione renale (p=0,03) e una significativa eliminazione dei depositi di C3, con il 71% dei pazienti trattati che ha raggiunto una completa clearance.
Questo trattamento innovativo 猫 rivolto a malattie renali rare che colpiscono 5.000 persone negli Stati Uniti, dove circa il 50% dei pazienti sviluppa insufficienza renale entro 5-10 anni dalla diagnosi. La terapia ha dimostrato efficacia sia nei pazienti adolescenti che adulti, inclusi quelli con recidiva della malattia dopo trapianto.
Apellis Pharmaceuticals (Nasdaq: APLS) ha recibido la aprobaci贸n de la FDA para EMPAVELI庐 (pegcetacoplan) como el primer tratamiento para la glomerulopat铆a C3 (C3G) y la glomerulonefritis membranoproliferativa por complejos inmunes primaria (IC-MPGN) en pacientes de 12 a帽os en adelante.
La aprobaci贸n se basa en los resultados del estudio de Fase 3 VALIANT, que mostr贸 tres logros clave: una reducci贸n del 68% en la proteinuria (p<0,0001), estabilizaci贸n de la funci贸n renal (p=0,03) y una eliminaci贸n sustancial de los dep贸sitos de C3, con el 71% de los pacientes tratados logrando una limpieza completa.
Este tratamiento innovador est谩 dirigido a enfermedades renales raras que afectan a 5,000 personas en Estados Unidos, donde aproximadamente el 50% de los pacientes progresa a insuficiencia renal dentro de los 5-10 a帽os posteriores al diagn贸stico. La terapia demostr贸 eficacia tanto en pacientes adolescentes como adultos, incluidos aquellos con recurrencia de la enfermedad tras trasplante.
Apellis Pharmaceuticals (雮橃姢雼�: APLS)電� 12靹� 鞚挫儊 頇橃瀽鞚� C3 靷惮觳措硲歃�(C3G) 氚� 鞗愲皽靹� 氅挫棴氤淀暕觳� 毵夓鞁濎劚 靷惮觳挫嫚鞐�(IC-MPGN)鞐� 雽�頃� 斓滌磮 旃橂鞝滊 EMPAVELI庐(韼橁犯靹疙儉旖滊澕韺�)鞐� 雽�頃� FDA 鞀轨澑鞚� 氚涭晿鞀惦媹雼�.
鞚措矆 鞀轨澑鞚� 3靸� VALIANT 鞐瓣惮 瓴瓣臣毳� 旮半皹鞙茧 頃橂┌, 靹� 臧�歆� 欤检殧 靹标臣毳� 氤挫棳欷嶋媹雼�: 雼氨雵� 68% 臧愳唽(p<0.0001), 鞁犾灔 旮半姤 鞎堨爼頇�(p=0.03), 攴鸽Μ瓿� C3 旃癌氍检潣 靸侂嫻頃� 鞝滉卑搿�, 旃橂氚涭潃 頇橃瀽鞚� 71%臧� 鞕勳爠 鞝滉卑毳� 雼劚頄堨姷雼堧嫟.
鞚� 順侅嫚鞝侅澑 旃橂氩曥潃 氙戈淡 雮� 鞎� 5,000氇�鞚� 頋穩 鞁犾灔 歆堩櫂 頇橃瀽鞐愱矊 鞝侅毄霅橂┌, 歆勲嫧 頉� 5-10雲� 雮� 鞎� 50%臧� 鞁犽秬鞝勳溂搿� 歆勴枆霅╇媹雼�. 鞚� 旃橂電� 觳唽雲� 氚� 靹膘澑 頇橃瀽 氇憪鞐愳劀 須臣毳� 鞛呾頄堨溂氅�, 鞚挫嫕 頉� 歆堩櫂 鞛皽 頇橃瀽鞐愱矊霃� 鞙犿毃頄堨姷雼堧嫟.
Apellis Pharmaceuticals (Nasdaq : APLS) a obtenu l'approbation de la FDA pour EMPAVELI庐 (pegcetacoplan), le premier traitement de la glom茅rulopathie C3 (C3G) et de la glom茅rulon茅phrite membranoprolif茅rative 脿 complexes immunitaires primaires (IC-MPGN) chez les patients 芒g茅s de 12 ans et plus.
Cette approbation repose sur les r茅sultats de l'茅tude de phase 3 VALIANT, qui a d茅montr茅 trois r茅alisations cl茅s : une r茅duction de 68 % de la prot茅inurie (p<0,0001), une stabilisation de la fonction r茅nale (p=0,03) et une 茅limination substantielle des d茅p么ts de C3, avec 71 % des patients trait茅s ayant obtenu une clairance compl猫te.
Ce traitement r茅volutionnaire cible des maladies r茅nales rares touchant 5 000 personnes aux 脡tats-Unis, dont environ 50 % des patients 茅voluent vers une insuffisance r茅nale dans les 5 脿 10 ans suivant le diagnostic. La th茅rapie a d茅montr茅 son efficacit茅 chez les adolescents et les adultes, y compris chez ceux pr茅sentant une r茅cidive de la maladie apr猫s une transplantation.
Apellis Pharmaceuticals (Nasdaq: APLS) hat die FDA-Zulassung f眉r EMPAVELI庐 (Pegcetacoplan) als erste Behandlung der C3-Glomerulopathie (C3G) und der prim盲ren immunvermittelten membranoproliferativen Glomerulonephritis (IC-MPGN) bei Patienten ab 12 Jahren erhalten.
Die Zulassung basiert auf den Ergebnissen der Phase-3-Studie VALIANT, die drei zentrale Erfolge zeigte: eine 68%ige Reduktion der Proteinurie (p<0,0001), Stabilisierung der Nierenfunktion (p=0,03) und eine erhebliche Beseitigung von C3-Ablagerungen, wobei 71% der behandelten Patienten eine vollst盲ndige Entfernung erreichten.
Diese bahnbrechende Behandlung richtet sich gegen seltene Nierenerkrankungen, die 5.000 Menschen in den USA betreffen, von denen etwa 50% innerhalb von 5-10 Jahren nach Diagnose eine Niereninsuffizienz entwickeln. Die Therapie zeigte Wirksamkeit sowohl bei Jugendlichen als auch Erwachsenen, einschlie脽lich Patienten mit Krankheitsr眉ckfall nach Transplantation.
- First-ever FDA-approved treatment for C3G and primary IC-MPGN
- Significant 68% reduction in proteinuria (p<0.0001)
- 71% of treated patients achieved complete clearance of C3 deposits
- Demonstrated efficacy in both adolescent and adult patients
- Well-established safety profile with >2,200 patient years across approved indications
- Broad label including post-transplant disease recurrence
- Risk of serious infections caused by encapsulated bacteria requiring REMS program
- Potential for infusion-related reactions including anaphylaxis
- Requires vaccination against encapsulated bacteria at least 2 weeks before treatment
Insights
FDA approval of EMPAVELI for rare kidney diseases represents significant commercial opportunity and validates Apellis' C3 platform technology.
The FDA approval of EMPAVELI (pegcetacoplan) marks a major therapeutic breakthrough for C3G and primary IC-MPGN patients. As the first approved treatment for these rare kidney diseases affecting approximately
The approval is particularly valuable as it covers a broad patient population - adults, adolescents (12+), and importantly, post-transplant C3G recurrence cases. The label's breadth maximizes the addressable patient population, which is critical for rare disease commercialization.
EMPAVELI demonstrated remarkable efficacy across all three disease markers in the Phase 3 VALIANT study:
68% reduction in proteinuria (primary endpoint, p<0.0001)- Stabilization of kidney function (measured by eGFR)
- Substantial clearance of C3 deposits with
71% of treated patients achieving complete clearance
This represents EMPAVELI's third approved indication in four years, validating Apellis' C3-targeting platform technology. The therapeutic approach shows strong translatability across complement-mediated diseases.
For context, without treatment, approximately
The established safety profile across 2,200+ patient years in approved indications reduces regulatory and commercial risks. The company's ApellisAssist program should facilitate patient access and reimbursement, critical factors for commercial uptake in rare diseases.
EMPAVELI represents a paradigm shift for C3G/IC-MPGN treatment, potentially preventing kidney failure by targeting disease mechanisms rather than symptoms.
This FDA approval represents a transformative development in the management of C3G and IC-MPGN. These rare kidney diseases have historically lacked specific treatments, with management limited to non-specific immunosuppression, renin-angiotensin system blockers, and supportive care - none addressing the underlying complement dysregulation.
The clinical impact is profound. The
The clearance of C3 deposits is mechanistically significant - these deposits drive inflammation and kidney damage. With
For pediatric nephrology, this approval is particularly significant as many C3G patients are diagnosed in adolescence. Without effective treatment, these young patients face decades of dialysis or multiple kidney transplants throughout their lifetime. Even after transplantation,
The inclusion of post-transplant recurrence in the approval is clinically crucial. Historically, patients would lose native kidneys to disease, receive transplants, only to have the disease recur and damage the transplanted kidney. Breaking this cycle represents a major advancement in transplant nephrology.
The safety profile appears manageable with appropriate vaccination protocols against encapsulated bacteria - a known class effect of complement inhibitors. The risk-benefit ratio strongly favors treatment given the severe consequences of disease progression.
- Proven efficacy across all three key markers of disease鈥�
68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits
- Broad label includes adults and adolescents with C3G or primary IC-MPGN, and post-transplant C3G disease recurrence
- Well-established safety profile, consistent across >2,200 patient years in approved indications
- C3G and primary IC-MPGN are rare kidney diseases with high risk of kidney failure
- Conference call tomorrow听at 8:00听a.m. ET
WALTHAM, Mass., July 28, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced听that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI庐 (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. C3G and primary IC-MPGN are rare kidney diseases, affecting 5,000 people in the United States.1
鈥淚鈥檓 excited to now have a highly effective therapy for a broad range of patients living with C3G and primary IC-MPGN,鈥� said Carla Nester, M.D., MSA, FASN, lead principal investigator for the VALIANT study, professor of internal medicine and pediatrics and director of pediatric nephrology, University of Iowa Stead Family Children's Hospital. 鈥淲ith standard of care, patients living with these rare and severe diseases frequently progress to kidney failure, necessitating lifelong dialysis and/or a kidney transplant. Given the urgent need, particularly in children, the approval of EMPAVELI marks a pivotal moment in the treatment of rare kidney diseases.鈥�
In the Phase 3 VALIANT study, EMPAVELI demonstrated an unprecedented
鈥淓MPAVELI has the potential to be truly transformational for patients with C3G and primary IC-MPGN, who until now have had very few treatment options. In the largest pivotal study of these diseases, EMPAVELI demonstrated its potential to preserve kidney function by controlling all three key markers of disease,鈥� said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer, Apellis. 鈥淎s Apellis鈥� third approval in four years, this milestone underscores the unique ability of targeting C3 to improve patients鈥� lives. We are deeply grateful to everyone who made this approval possible and look forward to building on this momentum as we advance pivotal studies of EMPAVELI in other rare kidney diseases.鈥�
鈥淭he approval of EMPAVELI is a historic milestone for people living with C3G and primary IC-MPGN, many of whom are adolescents or young adults,鈥� said听Josh Tarnoff, chief executive officer, NephCure.听鈥淲e recognize Apellis鈥� commitment to these patients and their families, and to the research and innovation that will bring this life-changing treatment into the hands of patients that need it most.鈥�
The approval of EMPAVELI is based on positive six-month results from the VALIANT study, demonstrating benefits across all three key markers of disease:
- Proteinuria reduction:听The study met its primary endpoint, demonstrating a statistically significant
68% (p<0.0001) proteinuria reduction in EMPAVELI-treated patients compared to placebo. - Stabilization of kidney function:听EMPAVELI-treated patients achieved stabilization of kidney function compared to placebo (nominal p=0.03) as measured by estimated glomerular filtration rate (eGFR).
- Reduction of C3 staining:听A majority of EMPAVELI-treated patients achieved a reduction in C3 staining intensity (nominal p<0.0001) compared to placebo.听
71% of EMPAVELI-treated patients achieved zero C3 staining intensity, demonstrating complete clearance of C3 deposits.听
The safety profile of EMPAVELI is well-established, with >2,200 patient years across all approved indications. The most common adverse reactions in the VALIANT study (鈮�
Apellis is committed to helping patients with treatment access and support. ApellisAssist庐 is a program designed to help EMPAVELI patients along their treatment journey by providing a comprehensive system of support including help navigating insurance coverage, financial assistance for eligible patients, disease education, and ongoing product support. Patients and healthcare providers can call 1-888-273-5547 for more information.
Conference Call and Webcast
Apellis will host a conference call and webcast to discuss the FDA鈥檚 approval of EMPAVELI tomorrow, July 29, 2025 at 8:00 a.m. ET. To access the live call by phone, please pre-register for the call听. A live audio webcast of the event and accompanying slides may also be accessed through the 鈥淓vents and Presentations鈥� page of the 鈥淚nvestors and Media鈥� section of the company鈥檚听. A replay of the webcast will be available for 30 days following the event.
About C3听Glomerulopathy (C3G) and听Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately
About the VALIANT Study
The VALIANT Phase 3 study () was a randomized, placebo-controlled, double-blinded, multi-center study that evaluated EMPAVELI庐 (pegcetacoplan) efficacy and safety in 124 patients who were 12 years of age and older with C3G or primary IC-MPGN. It is the largest single trial conducted in these populations and the only study to include pediatric and adult patients, with native and post-transplant kidneys. Study participants were randomized to receive EMPAVELI or placebo twice weekly for 26 weeks. Following this 26-week randomized controlled period, patients were able to proceed to a 26-week open-label phase in which all patients received EMPAVELI. The primary endpoint of the study was the log transformed ratio of urine protein-to-creatinine ratio (UPCR) at Week 26 compared to baseline.
About EMPAVELI庐/Aspaveli庐听(pegcetacoplan)
EMPAVELI庐/Aspaveli庐听(pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body鈥檚 immune system, which can lead to the onset and progression of many serious diseases. It is approved for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in the United States and paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally. The therapy is also under investigation for other rare diseases.
U.S. Important Safety Information for EMPAVELI
BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA
EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
- Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risks of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor.
- Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected.
Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS.
CONTRAINDICATIONS
- Hypersensitivity to pegcetacoplan or to any of the excipients
- For initiation in patients with unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B
WARNINGS AND PRECAUTIONS
Serious Infections Caused by Encapsulated Bacteria
EMPAVELI, a complement inhibitor, increases a patient鈥檚 susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis (caused by any serogroup, including non-groupable strains), and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria.
Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria.
Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections.
EMPAVELI is available only through a restricted program under a REMS.
EMPAVELI REMS
EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria. Notable requirements of the EMPAVELI REMS include the following:
Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risks, signs, and symptoms of serious infections caused by encapsulated bacteria, provide patients with the REMS educational materials, ensure patients are vaccinated against encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug prophylaxis if patients鈥� vaccine status is not up to date and treatment must be started urgently, and provide instructions to always carry the Patient Safety Card both during treatment, as well as for 2 months following last dose of EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified.
Further information is available at or 1-888-343-7073.
Infusion-Related Reactions
Systemic hypersensitivity reactions (eg, facial swelling, rash, urticaria, pyrexia) have occurred in patients treated with EMPAVELI, which may resolve after treatment with antihistamines. Cases of anaphylaxis leading to treatment discontinuation have been reported. If a severe hypersensitivity reaction (including anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute appropriate treatment, per standard of care, and monitor until signs and symptoms are resolved.
Interference with Laboratory Tests
There may be interference between silica reagents in coagulation panels and EMPAVELI that results in artificially prolonged activated partial thromboplastin time (aPTT); therefore, avoid the use of silica reagents in coagulation panels.
ADVERSE REACTIONS
Most common adverse reactions in adult and pediatric patients 12 years of age and older with C3G or primary IC-MPGN (incidence 鈮�
USE IN SPECIFIC POPULATIONS
Females of Reproductive Potential
EMPAVELI may cause embryo-fetal harm when administered to pregnant women. Pregnancy testing is recommended for females of reproductive potential prior to treatment with EMPAVELI. Advise female patients of reproductive potential to use effective contraception during treatment with EMPAVELI and for 40 days after the last dose.
Please see full , including Boxed WARNING regarding serious infections caused by encapsulated bacteria, and .
About Apellis
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit 听or follow us on and听.
Apellis Forward-Looking Statement听
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute 鈥渇orward-looking statements鈥� within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential market opportunity of EMPAVELI for C3G and IC-MPGN. The words 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渃ontinue,鈥� 鈥渃ould,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥減lan,鈥� 鈥減otential,鈥� 鈥減redict,鈥� 鈥減roject,鈥� 鈥渟hould,鈥� 鈥渢arget,鈥� 鈥渨ill,鈥� 鈥渨ould鈥� and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the clinical trial results of EMPAVELI for C3G and IC-MPGN indicate an effect that is greater than the actual positive effect; and any other factors discussed in the 鈥淩isk Factors鈥� section of Apellis鈥� Annual Report on Form 10-K with the Securities and Exchange Commission on February 28, 2025 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Media:
Tracy Vineis
617.420.4839
Investors:听
Neil Carnahan, CFA
617.977.5703
References
1. Data on file using literature consensus.听
2. Smith RJH, et al. Nat Rev Nephrol. 2019;15(3):129-143.
3. Servais A, et al. Kidney Int. 2012;82(4):454-464.
4. Zand L, et al. J Am Soc Nephrol. 2014;25(5):1110-1117.
5. Tarrag贸n, B, et al. C3 Glomerulopathy Recurs Early after Kidney Transplantation in Serial Biopsies Performed within the First 2 Years after Transplantation. Clinical Journal of the American Society of Nephrology. August 2024; 19(8)1005-1015. doi: 10.2215/CJN.0000000000000474.
A photo accompanying this announcement is available at
FAQ
What did the FDA approve EMPAVELI for in July 2025?
What were the key efficacy results from the VALIANT study for APLS's EMPAVELI?
How many patients are affected by C3G and IC-MPGN in the United States?
What are the main safety concerns with Apellis' EMPAVELI treatment?
What percentage of C3G and IC-MPGN patients progress to kidney failure?
