Fierce Biotech reported this morning that the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) voted to recommend several drugs for approval in Europe. Normally, CHMP's recommendation is followed and these would expected to receive formal approval in the next 3 months. With no further ado, the winners are:
- GSK and HGS received a recommendation for their new lupus drug, Benlysta (approved in US in March). It's the first new drug for lupus in 50 years and analysts have projected worldwide annual sales potential of $3 billion.
- CHMP reveresed itself and recommended Accorda Therapeutics' Fampyra for MS. Biogen Idec will be marketing the drug in Europe. Approval of Fampyra will trigger a $25 M milestone payment for Accorda.
- BMS received the good word on its new drug Yervoy (ipilimumab) for the treatment of metastatic melanoma. It will be the first new melanoma drug in Europe in a decade.
- Amgen's Xgeva (denosumab) got the okay for the prevention of skeletal-related events in adult cancer patients. The durg is also approved under the Prolia name for the treatment of osteoporosis.
- Finally, Pfizer and BMS got the European Commission's approval for Eliquis (apixaban) for the prevention of venous thromboembolic events (VTE) in adults who have undergone hip or knee replacements. It is the first market to approve this drug.
That's the next wave of new drugs one can expect on the European market and the next source of important revenues for these companies.
Posted by Bruce Lehr May 20th 2011.