In a joint meeting of the FDA’s Advisory Committee for Reproductive Health Drugs (ACRHD) and the Drug Safety and Risk Management Advisory Committee (DSaRM), panelists voted 12-9 that the risk of cancer from calcitonin outweigh its potential benefits for osteoporosis. The panel also voted 20-1 that developers of new calcitonin products would have to prove efficacy in the reduction of bone fractures.
The EMA warned against calcitonin nasal spray use in July 2012, a warning that Fortical nasal spray manufacturer Unigene called “catastrophic” for its business. Novartis, which markets Miacalcin calcitonin nasal spray, submitted briefing materials in which it says it believes that the data “indicate a potential risk of malignancy beyond 6 months needs to be balanced against the real benefit to these patients.”
In a briefing document for the meeting, FDA experts concluded, “At this time, the potential for a cancer risk associated with calcitonin use appears plausible, and certainly cannot be ruled out with the data reviewed. In this situation, when assessing the risks and benefits of calcitonin salmon therapy for treatment of postmenopausal osteoporosis, the question of the fracture reduction efficacy becomes critical.”
Read a Reuters report of the meeting.
Read the FDA briefing materials.
Read the Novartis briefing materials.
