- The U.S. Food and Drug Administration has extended the review of BioMarin Pharmaceutical Inc's experimental gene therapy for adults with a severe bleeding disorder, the latest delay in the company's quest to gain approval in the country.
The FDA said late on Monday it needed more time to review a three-year analysis from the company's ongoing late-stage study, which BioMarin submitted earlier this year, and will make a decision by June 30. The regulator had earlier set March 31 as its decision date. The potential one-time treatment, if approved, will be the first gene therapy for hemophilia A, a genetic bleeding disorder that affects one in 10,000 people and requires regular infusions of a blood clotting protein called factor VIII.
The FDA had rejected the drug in August 2020, citing the need for longer-term data. It was granted conditional marketing authorization in the European Union in August last year.
Business Business Latest News, Business Business Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Ken Griffin's Citadel extends winning streak in 2023 amid gains in stocksKen Griffin's Citadel extends winning streak in 2023 after last year's record gains, matching the broader rally in stocks
Source: BusinessInsider - 🏆 729. / 51 Read more »