FDA Approves BioMarin's ROCTAVIAN Gene Therapy For Adults With Severe Hemophilia A
Portfolio Pulse from Benzinga Newsdesk
The FDA has approved BioMarin's ROCTAVIAN gene therapy for adults with severe Hemophilia A. ROCTAVIAN is a one-time, single-dose treatment and its approval was based on durability, efficacy, and safety results from the largest and longest Phase 3 study for a gene therapy for Hemophilia. Majority of patients continued to respond to ROCTAVIAN treatment over 3 years.
June 29, 2023 | 6:38 pm
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POSITIVE IMPACT
BioMarin's ROCTAVIAN gene therapy has been approved by the FDA, which could potentially increase the company's market share in the Hemophilia treatment market.
FDA approval is a significant milestone for any pharmaceutical company. It allows the company to market and sell the drug in the US, which can lead to increased revenues. Given the positive results from the Phase 3 study, it is likely that ROCTAVIAN will be well received in the market, potentially leading to an increase in BioMarin's stock price in the short term.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100