The FDA has notified Biogen Idec that it needs more time to review its BLA for Alprolix after the drugmaker submitted additional data supporting the validation of a key manufacturing step.
The agency accepted the application for the drug, a hemophilia B treatment, in March, granting a standard review timeline of ten months. The extension gives the FDA an additional three months.
The application is largely based on the B-LONG Phase III trial, which showed that more than 90 percent of bleeding was controlled with just one injection of the drug, while more than 97 percent succeeded with up to two injections.
Alprolix is also currently under review in Canada, Australia and Japan. — Lena Freund
Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.