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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