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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]
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.
In February 2023, Apellis Pharmaceuticals received the first FDA approval of pegcetacoplan for the treatment of this condition. [35] Avacincaptad pegol (Izervay) was approved in the United States in August 2023 for the treatment of geographic atrophy secondary to age-related macular degeneration. [36] [37]
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.
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]
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
ATC code L04 Immunosuppressants is a therapeutic subgroup of the Anatomical Therapeutic Chemical Classification System, a system of alphanumeric codes developed by the World Health Organization (WHO) for the classification of drugs and other medical products.
The gene therapy will compete with Australia-based CSL Behring’s Hemgenix, a similar treatment that won FDA approval for hemophilia B in 2022. That drug has a similar list price of $3.5 million ...