EU Approval Recommended for Male Osteoporosis Drug

The Committee for Medicinal Products for Human Use (CHMP) has recommended Novartis’ drug Aclasta for EU approval in treating men with increased risk of fractures.

Additionally, the CHMP has recommended expanding the label to include data that show Aclasta reduced the risk of clinical fractures by 35 percent in men and postmenopausal women who have recently had a low-trauma hip fracture. The drug is the only osteoporosis treatment to demonstrate this benefit, according to Novartis.

Administered by once-yearly infusion, the drug received EU approval in 2007 for the treatment of osteoporosis in postmenopausal women. In the U.S., Aclasta is called Reclast.