The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use includes a number of extensions of indication and a recommendation for a new orphan drug.
First up, the CHMP is letting Eli Lilly change the indication on tadalafil to pulmonary arterial hypertension, to be sold as Adcirca, from erectile dysfunction (marketed as Cialis). The latter indication is being withdrawn by Lilly which has also received an extension for Cymbalta (duloxetine).
The drug, which is co-marketed by Boehringer Ingelheim as Xeristar, is currently authorised for the treatment of major depressive episodes, of diabetic peripheral neuropathic pain in adults and of generalised anxiety disorder. The label has now been extended to include major depressive disorder.
The Committee has also backed an extension to Boehringer’s Micardis (telmisartan) to include the reduction of cardiovascular morbidity in patients with “manifest atherothrombotic cardiovascular disease” or type 2 diabetes with documented target organ damage. The drug is currently authorised for the treatment of essential hypertension in adults.
In addition, the CHMP is allowing The Medicines Company to extend the indication on Angiox (bivalirudin) to include patients with ST-segment myocardial infarction undergoing primary percutaneous coronary intervention. It has also backed Ratiopharm’s version of Pfizer’s erectile dysfunction blockbuster Viagra (sildenafil) and a new formulation of Allergan’s Lumigan (bimatoprost) for glaucoma patients.
A positive opinion has also been bestowed on EUSA Pharma’s Zenas (amifampridine), for the treatment of Lambert-Eaton Myasthenic Syndrome, a rare disorder of neuromuscular transmission caused by impaired presynaptic release of acetylcholine. Zenas is the 59th orphan drug to be recommended by the CHMP.
Movetis’ Resolor approved
Meantime, Belgium’s Movetis has been boosted after obtaining approval from the European Commission for Resolor (prucalopride) for the treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.
The Turnhout-based company, which is considering an initial public offering as an option to raise capital to market Resolor, stated that it will sell the product itself in certain European markets. First launches are expected in the first quarter of 2010.
