OCTAPHARMA | MedPath

Biotest Submits Fibrinogen Biologics License Application to FDA

4 months ago

• Biotest has submitted a Biologics License Application (BLA) to the FDA for its Fibrinogen product, addressing acquired fibrinogen deficiency. • The application includes treatment and prophylaxis of acute bleeding episodes in patients with congenital fibrinogen deficiency, expanding its potential use. • Clinical data supports the efficacy and safety of Biotest's Fibrinogen, offering advantages over current treatments like fresh frozen plasma. • The FDA is expected to make a decision by the end of 2025, following a similar application submitted in Europe in October 2024.

Hemophilia B Therapeutics: Advances in Clinical Trials and Emerging Therapies

6 months ago

• Several companies are actively involved in developing therapies for Hemophilia B, with Belief Biomed's drug candidates reaching Phase III clinical trials. • Recent trials include Novo Nordisk's assessment of Nonacog Beta Pegol in Chinese patients and ApcinteX Ltd's study of SerpinPC in severe Hemophilia A or B. • Emerging therapies like BBM-H901 (Belief Biomed) and Fidanacogene elaparvovec (Pfizer/Spark Therapeutics) are under investigation across various clinical stages. • Hemophilia B therapies are being developed using various routes of administration, including oral, intravenous, and subcutaneous, and molecule types, such as gene therapy and recombinant fusion proteins.