IOF welcomes CHMP decision to re-examine marketing authorization for romosozumab

Committee for Medicinal Products for Human Use (CHMP) has announced a positive opinion recommending marketing authorization for romosozumab for the treatment of severe osteoporosis in postmenopausal women.

The International Osteoporosis Foundation (IOF) welcomes the decision by the Committee for Medicinal Products for Human Use (CHMP), following a re-examination procedure, to grant a marketing authorisation for romosozumab in the treatment of severe postmenopausal osteoporosis. This decision clearly represents a change in the previously perceived benefit-risk balance for the drug, and will enable patients in Europe to benefit from this novel intervention, joining many other countries worldwide.

We are delighted on behalf of these patients, and look forward to continuing our efforts to delineate the precise clinical settings in which clinicians might target its most effective utilisation.

IOF President, Cyrus Cooper
IOF CEO, Philippe Halbout