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Pegcetacoplan is the first treatment for paroxysmal nocturnal hemoglobinuria that binds to and inhibits complement protein C3. [9] Pegcetacoplan was approved for medical use in the United States in May 2021. [9] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [16]
Pegcetacoplan is the first treatment for paroxysmal nocturnal hemoglobinuria that binds to and inhibits complement protein C3. [51] Pegcetacoplan was approved for medical use in the United States in May 2021. [51] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [52]
The FDA accepts Apellis' (APLS) major amendment to the NDA for pegcetacoplan to treat geographic atrophy secondary to age-related macular degeneration. A decision is now due on Feb 26, 2023. Stock up.
Iptacopan was approved for medical use in the European Union in May 2024. [5] In August 2024, the US FDA granted accelerated approval to Fabhalta (iptacopan) for reducing proteinuria in adults with primary IgA nephropathy (IgAN). [12]
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form. [11]
The FDA approval in 2011 was based on two small prospective trials of 17 people and 20 people. [ 15 ] [ 8 ] [ 23 ] The European Medicines Agency approved it for the treatment of paroxysmal nocturnal hemoglobinuria in June 2007, [ 7 ] and in November 2011, for the treatment of atypical hemolytic uremic syndrome. [ 24 ]
Drug class: Complement inhibitor: ATC code: S01XA32 ; Legal status; ... Avacincaptad pegol was approved for medical use in the United States in August 2023. [2] [3] [4]
Piflufolastat (18 F) was approved for medical use in the United States in May 2021. [1] [6] [4] It is the second PSMA-targeted PET imaging drug approved by the U.S. Food and Drug Administration (FDA). [4] The first approved PSMA-targeted PET imaging drug is Ga 68 PSMA-11. [4]