FDA advisory committee recommends approval for tipranavir – material from hearing online

15 June 2005. Related: Antiretrovirals.

On May 19 the FDA advisory committee recommended accelerated approval for tipranavir , manufactured by Boehringer Ingelheim for the treatment of HIV. The proposed trade name for tipranavir is Aptivus.

The panel acknowledged the urgent need for new treatments that would work for patients who are resistant to current drugs. Concern about possible liver damage and adverse reactions with other commonly used medicines such as cholesterol and diabetes drugs was raised. They also noted an increased incidence of rash in female patients, who comprised just 15 percent of clinical study subjects.

The final decision is expected to be formally announced around June 22, but committee recommendations are always generally followed.

Background material including the detailed submission on tipranavir is on the FDA website:
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4139b1.htm

Source: FDA listserve.