Aptivus clears FDA for HIV: Labeling for Boehringer Ingelheim's HIV agent Aptivus (tipranavir) advocates use of genotypic or phenotypic testing and/or treatment history to help guide therapy. The non-peptidic protease inhibitor received accelerated approval June 22 for use with Abbott's Norvir (ritonavir) for "treatment of HIV-1 infected adult patients with evidence of viral replication, who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors." Accelerated approval was based on response rate in two 24-week, open-label Phase III trials; to support full approval, BI will submit 48-week data from two ongoing Phase III studies by Sept. 30, 2006. Postmarketing studies will look at therapeutic drug monitoring and drug-drug interactions. Like other protease inhibitors, Aptivus has an extensive interaction profile: it is either contraindicated or "not recommended" for concomitant use with 19 drugs...

CV Therapeutics’ Ranexa could receive the first approval for first-line treatment of chronic angina if a new outcomes trial does not detect a trend towards death or arrhythmia, the company said.

Novo Nordisk expects European approval of Levemir (insulin detemir) "within the coming months" following a positive opinion from the EU's Committee on Proprietary Medicinal Products, the company announces Feb. 27. European launch is slated for second-half 2004. The long-acting insulin analog was deemed "approvable" for treatment of diabetes by FDA Oct. 7, 2003, pending resolution of "certain clinical issues" (1Pharmaceutical Approvals Monthly Nov. 1, 2003, p. 3)...