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.

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FDA approves new HIV drug Aptivus

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