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EU Panel: Positive Opinion On Sildenafil Ratiopharm

LONDON -(Dow Jones)- The European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, said Friday it has adopted a positive opinion for Sildenafil ratiopharm, from ratiopharm GmbH, a generic of Viagra, indicated for the treatment of erectile dysfunction.

MAIN FACTS:

-Positive Opinion for Generic Medicines:

Leflunomide Winthrop (leflunomide), from Sanofi-Aventis Deutschland GmbH ( SAN.FR), intended for the treatment of adult patients with active rheumatoid arthritis and with active psoriatic arthritis.

Extensions of indication - positive opinions

Adcirca (tadalafil), from Eli Lilly Nederland B.V., to change the indication to pulmonary arterial hypertension.

Angiox (bivalirudin), from The Medicines Company U.K. Ltd, to extend the indication to include patients with ST-segment myocardial infarction undergoing primary percutaneous coronary intervention (PCI).

Angiox is currently authorised for treatment of adult patients with acute coronary syndromes (unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI)) planned for urgent or early surgical intervention.

Cymbalta (duloxetine), from Eli Lilly Nederland B. V., and Xeristar ( duloxetine), from Boehringer Ingelheim International GmbH, to extend the indication of these medicines to include treatment of major depressive disorder.

Micardis (telmisartan), from Boehringer Ingelheim International GmbH, Pritor (telmisartan), from Bayer Schering Pharma AG, and Kinzalmono (telmisartan), from Bayer Schering Pharma AG, to extend the indication to include the reduction of cardiovascular morbidity in patients with manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease), or type 2 diabetes mellitus with documented target organ damage.

-Positive opinions for new medicines:

Scintimun (besilesomab), from CIS bio international, a radiopharmaceutical intended for use in scintigraphic imaging, in conjunction with other appropriate imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis.

Zenas (amifampridine), from EUSA Pharma SAS, intended for the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults, a rare disorder of neuromuscular transmission caused by impaired presynaptic release of acetylcholine (Ach). The review of Zenas began on 25 June 2008, with an active review time of 196 days.

-By London Bureau, Dow Jones Newswires; Contact Ian Walker; +44 (0)20 7842 9296; ian.walker@dowjones.com

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