BioCentury
ARTICLE | Clinical News

Calcitonin salmon regulatory update

March 11, 2013 7:00 AM UTC

FDA's Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee voted 12-9 that the overall benefit-risk assessment does not support the continued marketing of calcitonin salmon to treat osteoporosis in women >5 years after menopause. The committees also voted 20-1 that calcitonin products under development should be required to provide fracture efficacy data for approval for treatment or prevention of postmenopausal osteoporosis indications. Last year, EMA's CHMP recommended that calcitonin-containing medicines be used only for short-term treatment because of an increased risk of cancer associated with long-term use. The committee also said calcitonin has limited efficacy for treating postmenopausal osteoporosis and said the benefits of calcitonin-containing medicines for the indication do not outweigh the risks (see BioCentury, Aug. 13, 2012). ...