Novartis's bone drug recommended for treatment of osteoporosis in men

Jul 29, 2008 (Datamonitor via COMTEX) -- NVS | Quote | Chart | News | PowerRating -- Novartis has announced that the Committee for Medicinal Products for Human Use has recommended EU approval for once-yearly Aclasta to treat osteoporosis in men who are at increased risk of fractures.

In addition, the Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the label to include data showing that Aclasta reduced the risk of new clinical fractures by 35% in men and postmenopausal women who have recently had a low-trauma hip fracture.

The revised label also includes data showing that in this patient population, all-cause mortality was reduced by 28% in the Aclasta-treated group compared to patients receiving placebo or dummy drug.

The positive opinion was issued by the CHMP, which reviews medicines for the European Commission (EC). The EC generally follows the CHMP's recommendations and delivers its final decision within three months. The decision will apply in all 27 EU member states plus Iceland and Norway.

Trevor Mundel, global head of development functions at Novartis Pharma, said: "Aclasta represents a new treatment option that is administered as a once-yearly infusion, unlike daily, weekly or monthly oral bisphosphonates. Therefore Aclasta may allow osteoporotic men and women to receive a full year's bisphosphonate protection against the consequences of osteoporosis."

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