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2024-05-10 10:57 Apellis Announces U.S. Food and Drug Administration ( FDA ) Approval of EMPAVELI ™ ( pegcetacoplan ) for Adults with Paroxysmal No ... Release Details Apellis Announces U.S. Food and Drug Administration ( FDA ) Approval of EMPAVELI ™ ( pegcetacoplan ) for Adults with Paroxysmal Nocturnal Hemoglobinuria ( PNH ) May 14 , 2021 EMPAVELI , the first targeted C3 therapy , is approved for use in adults with PNH who are : Treatment naïve Switching from C5 inhibitor SolirisⓇ ( eculizumab ) Switching from C5 inhibitor UltomirisⓇ ( ravulizumab ) EMPAVELI was superior to Soliris for the change from baseline in hemoglobin level at Week 16 in the Phase 3 PEGASUS study 85 % of patients treated with EMPAVELI were transfusion free compared to 15 % on Soliris at Week 16 ; EMPAVELI met non - inferiority compared to Soliris on transfusion avoidance Apellis to host investor conference call on Monday , May 17 at 8:00 a.m. ET 1/4 T Dosage : Seepreciting Soyage F the can to pred Keep of ch REMOVE A SINGLE VAL CARTON FRON REFRIGERATOR FOR LEAST WINTES PRIOR TO USE DISCARD UNUSED PORTOL EACH INAL CONDANG 50 NDC 73606-010-01 EMPAVELI ™ ( pegcetacoplan ) Injection 1,080 mg / 20 mL ( 54 mg / mL ) For Subcutaneous Infusion Only Dispense the enclosed Medication Guide to each patient One 20 ml . Single - Dose Vial Discard unused portion . Rx only Apellis NDC 73606-010-01 EMPAVEL [ pegcetacoplan ) Injection 1,080 mg / 20 mL ( 54 mg / mL ) For Subcutaneous Infusion Only Rx only EMPAVELI ™ single - dose carton and vial ↑ 0 Apellis WALTHAM , Mass . , May 14 , 2021 ( GLOBE NEWSWIRE ) -- Apellis Pharmaceuticals , Inc. ( Nasdaq : APLS ) , a global biopharmaceutical company and leader in targeted C3 therapies , today announced that the U.S. Food and Drug Administration ( FDA ) has approved EMPAVELITM ( pegcetacoplan ) , the first and only targeted C3 therapy for treatment of adults with paroxysmal nocturnal hemoglobinuria ( PNH ) . EMPAVELI is approved for use in adults with PNH who are treatment naïve as well as patients switching from the C5 inhibitors SolirisⓇ ( eculizumab ) and UltomirisⓇ ( ravulizumab ) . https://investors.apellis.com/news-releases/news-release-details/apellis-announces-us-food-and-drug-administration-fda-approval 1/5 15