Posicor Approved In USA For Hypertension, Angina

Roche's new treatment for hypertension and angina pectoris, Posicor(mibefradil), has now been approved in the USA. The drug has also been registered in Switzerland, the Netherlands and several countries in Latin America and Asia.

A spokesman for Roche told the Marketletter that a launch in the USA is scheduled for July, and this is probably going to be the first country where the drug will be made available. Pricing plans have not yet been disclosed. Roche has highlighted mibefradil as one of the key new agents in its pipeline (Marketletter February 17).

The approval was based on studies involving more than 3,400 patients, which indicated that a single daily dose of 50mg-100mg was effective in the 24-hour control of blood pressure and in increasing exercise tolerance, with a decreased number of attacks, in angina patients. The drug was well-tolerated, with a safety profile similar to that of placebo at the 50mg dose. At 100mg/day, the most common side effects included headache, dizziness and leg edema.