Amgen reveals CHMP’s positive indication for Prolia

Amgen has revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for the marketing authorisation of Prolia (denosumab).

The drug is indicated to treat osteoporosis in postmenopausal women at increased risk of fractures, as well as bone loss associated with hormone ablation in men with prostate cancer.

If Prolia is approved by the European commission, Amgen will receive marketing authorisation for the drug in all EU countries.

Roger Perlmutter, executive vice-president of research and development at Amgen, commented: “With its ability to significantly reduce fractures at key skeletal sites throughout the body, a favorable benefit-risk profile, and convenient dosing every six months, Prolia addresses an important unmet medical need.”

In related news, Amgen entered into an agreement with Array BioPharma last week that will see the two companies working together in the development of new treatments for type 2 diabetes.