Trimeris and partner Roche have submitted 48-week efficacy and safety data from two pivotal studies of HIV fusion inhibitor Fuzeon to the FDA to support the drug’s full approval.

The data demonstrates that the utility of Fuzeon in combination regimens for the treatment of HIV can be extended to at least 48 weeks, the companies report.

The application was submitted only nine months after the FDA granted accelerated approval for Fuzeon on the basis of 24-week pivotal data. Accelerated approval is a special regulatory status granted by the FDA for approval of a drug that is used to treat patients with serious or life-threatening illnesses and that provides benefit to patients over existing treatments.

Final approval would be granted based on the duration of response that can be achieved with Fuzeon-based regimens.

Trimeris: www.trimeris.com