First Approval Of Zanidip Granted In UK

Recordati of Italy has been granted the first world marketing authorization for its new once-daily calcium channel blocker, Zanidip (lercanidipine), by the UK Medicines Control Agency. The product is indicated for the treatment of hypertension.

Recordati notes that lercanidipine is a long-acting, vasoselective calcium antagonist with a gradual onset of action, which lacks inotropic effects, has an excellent safety profile, does not affect heart rate and does not cause ankle edema, Recordati states. The company said it would be filing for approval of the drug in other European Union member states, via the mutual recognition procedure, within the next few months, and hopes to launch it in a number of major EU markets, as well as in British Commonwealth countries, before the end of the year.

Clinical trials of the agent in angina are also advancing, said Arrigo Recordati, chairman and chief executive of the firm.