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Pfizer Reports the P-III (BASIS) Study Data Evaluating HYMPAVZI to Treat Hemophilia A or B with Inhibitors

Shots: Pfizer reported positive topline results from the P‑III (BASIS) study evaluating HYMPAVZI (marstacimab) in hemophilia A or B pts (N=48) with inhibitors, meeting the 1EP and demonstrating a 93% reduction in annualized bleeding rate (ABR) vs. on‑demand treatment (1.39 vs. 19.78; p < 0.0001)  over 12mos. HYMPAVZI, a once‑weekly SC therapy that targets TFPI,…
June 27, 2025

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Pfizer New
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Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

  Shots:    The EC has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs., at least 35kg) with hemophilia A & B, without FVIII & FIX inhibitors, respectively. It is valid across the EU plus Iceland, Liechtenstein & Norway  Approval was based on pivotal P-III (BASIS) study of Hympavzi…
November 20, 2024

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EMA Marketing Authorization of New Drugs in September 2024
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EMA Marketing Authorization of New Drugs in September 2024

Shots:    The EMA’s CHMP has granted positive opinion to 4 Biologics and 1 New Chemical Entity in September 2024, leading to treatments for patients and advances in the healthcare industry   The major highlighted drugs were AbbVie’s Elahere to treat Ovarian Cancer and Pfizer’s Hympavzi for Hemophilia A and B  PharmaShots has compiled a list of 3 drugs that have been…
October 24, 2024

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Pfizer
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Pfizer Reports the US FDA’s Approval of Hympavzi to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents 

Shots:    The US FDA has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs.) with hemophilia A & B without FVIII & FIX inhibitors, respectively. It has also received the CHMP’s positive opinion for the same  Results from pivotal P-III (BASIS) study, assessing Hympavzi in patients (12-75yrs.) with severe…
October 11, 2024

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Pfizer
NEWS

Pfizer Reports the CHMP’s Positive Opinion of Hympavzi (Marstacimab) to Treat Hemophilia A and B 

      Shots:    The CHMP has recommended Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs.) with hemophilia A & B without FVIII & FIX inhibitors, respectively   The opinion was based on data of 116 subjects (12-75yrs.) from a pivotal P-III (BASIS) study treated with marstacimab (300mg loading dose followed by…
September 20, 2024

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