The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use have brought some good news for GlaxoSmithKline, Merck & Co, Bristol-Myers Squibb and Amgen, as well as Astellas and Biogen Idec.
First up, the CHMP has recommended approval of GSK and Human Genome Sciences’ lupus drug Benlysta (belimumab). Already available in the USA, where it is the first new drug for the disease to be approved in 50 years, analysts believe it will be a blockbuster.
Similar status is being predicted for Yervoy (ipilimumab), from Bristol-Myers Squibb which has been granted a positive opinion for the treatment of advanced melanoma in adults who have received prior therapy. The first such drug for the disease in over a decade, Yervoy was approved by the US Food and Drug Administration in March.
The European regulator is also likely to follow its US counterpart’s recent decision in giving the green light to Merck’s Victrelis (boceprevir) for the treatment of chronic hepatitis-C genotype-1 infection, in combination with peginterferon alpha and ribavirin, in adult patients with compensated liver disease who are previously untreated or for whom therapy has failed. The CHMP’s positive opinion comes just 120 days after a review began on the first-in-class protease inhibitor, reflecting unmet medical need.
The committee has also given its backing to Amgen’s Xgeva (denosumab) for the prevention of skeletal-related events in adults with bone metastases from solid tumours. The drug is already approved under the brand-name Prolia, for osteoporosis, and Amgen has also just released Phase III data which showed that denosumab significantly increased bone metastasis-free survival for more than four months in men with advanced prostate cancer that has not yet spread to bone.
The CHMP has also recommended Astellas/Theravance’s Vibativ (telavancin) for the treatment of adults with nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA). This is the first antibacterial medicine to receive a positive CHMP opinion in two years, “albeit in a restricted indication, addressing an increased need for new antibiotics”.
U-turn over Biogen’s Fampyra concluded
Also celebrating is Biogen after the CHMP overturned a previous negative opinion issued in January and adopted a final positive opinion, recommending conditional marketing authorisation for Fampyra (fampridine), which is intended to improve walking in adults suffering from multiple sclerosis.
Biogen will have to carry out a “long-term efficacy and safety study to investigate a broader primary endpoint that is clinically meaningful in terms of walking ability”, the CHMP noted, and “evaluate the early identification of responders in order to guide further treatment”.
The drug was developed by Acorda Therapeutics in the USA where it is sold as Ampyra (dalfampridine). The CHMP nod triggers a $25 million milestone payment to Acorda.
