Monday, September 24, 2012

Novartis AG (NYSE:NVS), Pfizer Inc.(NYSE:PFE), along with Other Drug Companies get Green Signal from EU Regulator

Vivus’s shares plummeted due to its obesity drug not being approved in Europe, but Pfizer Inc.(NYSE:PFE), Bristol-Myers Squibb, along with a bunch of other pharma companies gained endorsements for their new therapies from the European Union's drug regulator. The European Commission will pass the final decision regarding the companies' drug apps.

Pfizer and Bristol's Eliquis (apixaban) was approved by The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for a new use. This drug is an anti-clotting agent that helps to eliminate risks of stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF) and at least one other risk factor for stroke.

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The companies have huge hopes for apixaban on the large AF market, in spite of the obstacle during the summer when the FDA delayed in giving them a green signal for the drug. A year ago, this drug was approved in Europe in a market that is more restricted than AF.

Regeneron and Bayer's Eylea were approved by the EU regulator, according to Reuters. This drug is used for treating patients affected with wet age-related macular degeneration, a major cause of blindness in elders. The drug is priced below Roche’s Lucentis and also needs a lesser number of injections into the eye.

Novartis AG (ADR)(NYSE:NVS)’s Votubia (everolimus) for adults with non-cancerous renal angiomyolipoma associated with tuberous sclerosis complex (TSC), based on a variety of risk factors, was also given a go-ahead. The Type II diabetes drug Trajenta (linagliptin), from Boehringer Ingelheim and Eli Lilly was recommended by the CHMP as well. This drug could be administered with insulin and with or without metformin when required, to regulate glycemic control.

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