Unigene Laboratories, which manufactures Fortical calcitonin nasal spray for the treatment of osteoporosis, has requested product safety data submitted to the EMA’s Committee for Medicinal Products for Human Use (CHMP) in response to the EMA’s recommendation against use of calcitonin nasal sprays. The EMA report, issued on July 19, 2012, notes a 2.4% increase in the risk of cancer for nasal calcitonin formulations.
As a result, the EMA says, “Taking into account the increased rate of cancer with long-term use and the limited benefit of calcitonin when used to treat post-menopausal osteoporosis to reduce the risk of vertebral fractures, the CHMP concluded that the benefits of calcitonin did not outweigh the risks in this condition. As the nasal spray is only used in osteoporosis, the CHMP recommended that this formulation should no longer be used.”
Unigene President and CEO Ashleigh Palmer responded, “We are extremely surprised by the EMA’s recent recommendation concerning certain products containing calcitonin, a therapeutic agent that has been approved for use in Europe since 1973. It is important that we obtain and study the safety data for the specific European products that were reviewed by the CHMP to better understand the rationale behind the EMA’s conclusion.”
Fortical is marketed by Upsher-Smith in the US, and the company is developing an oral formulation. Novartis markets its calcitonin nasal spray as Miacalcin in the US and as Miacalcic in Europe.
Read the Unigene press release.
Read the EMA statement on calcitonin.
