CHMP recommends approval of a host of new drugs
Some big news has come out of a key advisory committee for European drug approvals. In addition to backing approval of Merck's ($MRK) hepatitis C drug Victrelis (boceprevir), European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) today announced a host recommendations. The EU's executive commission will likely rule for final approval of these drugs within the next three months.
- The CHMP backed GlaxoSmithKline ($GSK) and Human Genome Sciences' ($HGSI) lupus drug Benlysta, which won a landmark in the U.S. in March as the first new drug for the disease in 50 years. European approval is essential to helping GSK and HGS execute up to $3 billion in peak worldwide sales. But it could be a while before the developers hit that figure; ISI Group analyst Mark Schoenebaum tells Reuters that GSK and HGS will have to negotiate reimbursement for Benlysta in a number of countries, delaying "meaningful sales" numbers until 2012. Report | Report
- Acorda Therapeutics' ($ACOR) stock got a bump on news that the CHMP reversed its earlier recommendation against Fampyra, a drug designed to improve walking ability in multiple sclerosis patients. The panel recommended conditional approval of the drug, which will be marketed by Biogen Idec ($BIIB) in Europe. Approval of Fampyra in the EU could trigger a $25 million milestone payment to Acorda and up to $375 in other regulatory and sales milestones, according to Dow Jones. Report
- Bristol-Myers Squibb's ($BMY) drug Yervoy (ipilimumab) received a positive opinion for the treatment of patients with previously-treated unresectable or metastatic melanoma. If approved, Yervoy would be the first new melanoma treatment approved in Europe in a decade. BMS release
- Finally, Amgen's ($AMGN) Xgeva (denosumab) was recommended for the prevention of skeletal-related events in adult cancer patients. Amgen could get an extra year of marketing exclusivity for Xgeva in the EU since the indication was considered significantly new. The drug was also approved under the name Prolia for osteoperosis. Amgen release
ALSO: The European Commission has approved Pfizer and BMS's Eliquis (apixaban) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. It's the drug's first approval for any condition and in any market. Eliquis will compete with other next-generation anti-clotting treatments like Boehringer Ingelheim's Pradaxa and Xarelto from Bayer and Johnson & Johnson. Pfizer release
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