A salmon hormone used to treat post-menopausal osteoporosis may not reduce bone fractures enough to outweigh the drug’s cancer risks, U.S. regulators said.
Three studies on oral, injectable and nasal calcitonin-salmon formulations sold by Novartis AG (NOVN), Upsher-Smith Laboratories Inc., and other companies showed unreliable or disappointing results, Food and Drug Administration staff said today in a report. Additional research showed the cancer risk associated with such drugs appears plausible, the staff said.
FDA advisers plan to meet next week to decide if the risks and level of efficacy mean they should recommend sales of calcitonin-salmon drugs be discontinued in the U.S. The European Medicines Agency recommended last year that calcitonin-containing medicines sold in that region shouldn’t be used to treat the bone-weakening condition osteoporosis.
“This lack of effectiveness when combined with the potential for a cancer risk associated with calcitonin salmon therapy raises concerns about the overall risk and benefit assessment,” FDA staff said.
Calcitonin is a hormone that increases the amount of calcium in the bones, while lowering levels in the blood.
Novartis’ Miacalcin was approved in the U.S. in 1986 as an injection and in 1995 as a nasal spray. U.S. sales of the drug were about $14 million last year, Julie Masow, a spokeswoman for the Basel Switzerland-based company, said in an e-mail. About 28,000 prescriptions of Novartis’s Miacalcin were dispensed last year, a drop from 54,000 in 2011, Masow said.
Closely held Upsher-Smith, based in Maple Grove, Minnesota, makes Fortical, which was approved in 2005.
The European Medicines Agency reviewed data from an experimental medicine and the approved drugs and determined the risk of developing cancer was 0.7 percent higher in patients using an oral formulation being studied and 2.4 percent higher in patients using the nasal spray compared to those who took a placebo.
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