FDA sanctioned Novartis’ Reclast for the treatment of postmenopausal osteoporosis. Unlike oral bisphosphonate therapies that have to be taken daily, weekly, or monthly, Reclast is given as a once-yearly, 15-minute intravenous infusion.
"The fact that Reclast is highly effective and can be administered once-yearly represents a major milestone in the treatment of postmenopausal osteoporosis," points out Felicia Cosman, M.D., professor of clinical medicine, Columbia University, and principal investigator on Novartis’ clinical program for the drug.
The Committee for Medicinal Products for Human Use (CHMP) also issued a positive opinion recommending approval for the medicine in the EU, under the brand name Aclasta.
The regulatory submissions were based on efficacy and safety data from a three-year trial. Results reportedly increased bone strength and reduced fractures in areas of the body typically affected by osteoporosis.
Reclast/Aclasta is already marketed in the U.S., Canada, and the EU for the treatment of Paget's disease.
Novartis reports that additional studies are ongoing to examine the use of Reclast to prevent fractures following a hip fracture in men and women, treatment of corticosteroid-induced osteoporosis, and male osteoporosis.