Positive Verdict On Roche's Posicor From FDA Panel

Roche's new once-daily calcium channel blocker Posicor (mibefradil) hasbeen recommended for US approval by a Food and Drug Administration panel by five votes to three. Roche is seeking to market the drug for hypertension and chronic stable angina pectoris.

The drug was recently approved in its first market, the Netherlands, and in Switzerland. The Netherlands is the reference country for the pan-European approval procedure, according to Roche.

Posicor has been classified as a new class of calcium antagonist by the World Health Organization, and it is the only drug known to selectively block T-type calcium channels in addition to L-type channels. It is thought that this effect on T-type channels may confer some of mibefradil's unique properties, ie lowering heart rate without reducing cardiac contractility.