Approval is reportedly the first to allow dosing every two years.
FDA approved Novartis’ Reclast(r) as the first two-yearly treatment for the prevention of postmenopausal osteoporosis. The agency based its approval on the results of a study in over 500 postmenopausal women with osteopenia, which showed that a single infusion of Reclast significantly increased bone mineral density even after two years.
Reclast, which is sold as Aclasta(r) in non-U.S. territories, is already approved as a once-yearly infusion for the treatment of postmenopausal osteoporosis in over 80 countries including the U.S. and nations in the EU. In some countries the drug is also approved for increasing bone mass in men with osteoporosis and preventing osteoporosis caused by steroid therapy. Reclast/Aclasta is also sanctioned in the EU and U.S. for the treatment of Paget’s disease in men and women.
Full year sales of Reclast/Aclasta in 2008 were $254 million. Net sales in the first quarter of 2009 were $85 million, up 128% from the previous year’s quarter. Novartis notes that this was thanks largely to increasing access to patient infusion centers and improved reimbursement. As of Q1 2009 there were some 5,700 infusion centers established in the U.S., more than double the number in early 2008.