Schering receives EU approval for Ventavis

The European Commission in a Centralised Procedure has approved Schering's new drug Ventavis for marketing in all EU countries.

Ventavis is an inhalation treatment for patients with primary pulmonary hypertension, and is the only prostacyclin product that targets the pulmonary vessels more directly by inhalation.

Schering plans to start marketing the therapy in the first EU countries in 2003 and to roll out the product in Europe fully by 2004. Ventavis was designated as an orphan medicinal product in December 2000 and will fall under orphan drug protection until 2013.

The active substance is iloprost, a synthetic prostacyclin analogue. The pharmacological effects after inhalation of Ventavis are direct vasodilatation of the pulmonary arterial bed with consecutive significant improvement of pulmonary artery pressure, pulmonary vascular resistance and cardiac output as well as mixed venous oxygen saturation.

'Ventavis improves the therapy for patients affected by severe symptoms and heart failure,' said Dr Hubertus Erlen, ceo and chairman of the executive board of Berlin-based Schering AG. 'We will offer it as soon as possible to doctors and patients in the EU countries.'