Durham-based Trimeris Inc. and pharmaceutical giant Roche have submitted 48-week data from two studies
of FUZEON to the U.S. Food and Drug Administration, as the companies seek full approval for the AIDS
drug. The data demonstrates that the addition of FUZEON to an anti-HIV drug regimen offers a significant
reduction in the levels of the AIDS-causing virus and improvement in immune function over the 48-week
span, company officials said.
The application was submitted nine months after the FDA granted accelerated approval for FUZEON, the
first and only fusion inhibitor for the treatment of HIV, on the basis of 24-week pivotal data accelerated
approval. 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 meaningful
therapeutic benefit to patients over existing treatments.
Trimeris is a CED member.