Boehringer Ingelheim Pharmaceuticals Inc. announced that it has received full approval from the FDA for Aptivus. It had already received accelerated approval in June of 2005. Full approval was granted on data from a 48-week analysis of the Phase 3 clinic studies.
"Data show that APTIVUS/r may provide treatment-experienced HIV patients with an effective treatment option through nearly one year of therapy. Furthermore, longer-term safety data are now available for physician and patient consideration," said Dr. Daniel Kuritzkes, associate professor of medicine, Harvard Medical School; director of AIDS research, Brigham and Women's Hospital, Boston, MA.
Aptivus has already been approved in Argentina, Australia, Canada, Switzerland, Mexico, Iceland, Taiwan and the European Union.
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