New drug-resistant HIV treatment recommended
pharmafile | July 28, 2005 | News story | Sales and Marketing |
Boehringer Ingelheim's new treatment for patients with drug-resistant HIV has been recommended for approval by the European regulator.
The prevalence of drug-resistant HIV varies from region to region, but is a growing problem globally, and Aptivus (tipranavir) has been fast-tracked to meet the need.
The EMEA medicines committee has recommended Aptivus for approval, with final clearance expected to come in the fourth quarter of 2005.
The drug is a non-peptidic protease inhibitor (NPPI) and will be given to highly pre-treated patients with virus resistant to multiple protease inhibitors.
The company's RESIST trial found Aptivus producing superior viral load reduction and CD4 cell count increase compared to lopinavir/r (Abbott's Kaletra), ritonavir-boosted amprenavir (GSK's Agenerase) or saquinavir (Roche's Invirase).
The drug gained US approval in June and in Mexico the following month, and is under review by other regulators worldwide.
Related articles:
FDA approves new HIV drug Aptivus
Friday , July 01, 2005