Salmon-Derived Osteoporosis Drugs Face Upstream Struggle Against Cancer Concerns
This article was originally published in The Pink Sheet Daily
A March 5 joint meeting of the FDA advisory committees for Reproductive Health Drugs and Drug Safety and Risk Management will consider whether the benefit of taking calcitonin salmon, a hormone that increases the amount of calcium in the bones, to treat postmenopausal osteoporosis outweighs the potential risk of cancer; in July 2012, the European Medicines Agency concluded the risk with long-term use was too great and eliminated the osteoporosis indication for calcitonins.
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Saying its review found “no conclusive evidence of a causal relationship” between the products and cancer, agency is allowing continued marketing of Miacalcin and Fortical nasal sprays but limiting use to only those post-menopausal women for whom alternative treatments are not suitable.
Privately held firm believes oral calcitonin will enjoy several advantages over other osteoporosis therapies – ease of use compared to calcitonin nasal spray and safety compared to bisphosphonates.
Novartis announced Jan. 13 the elimination of nearly 2,000 positions in its U.S. General Medicines business in the wake of the termination of a key clinical study of Tekturna and in anticipation of the expiration of Diovan’s U.S. patent later this year.