Radius Health provides update on CHMP opinion for abaloparatide SC

Radius Health

22 March 2018 - Radius Health today announced that after an oral explanation the CHMP, the scientific committee of the EMA, has communicated a negative trend vote on the benefit-risk balance for the Company's marketing authorisation application for abaloparatide SC for the treatment of osteoporosis in postmenopausal women at increased risk for fracture. 

The EMA has informed the Company that the CHMP will therefore adopt a negative opinion on the application today, Thursday, March 22, 2018. The Company expects that the EMA will provide further information related to its decision on its website at www.ema.europa.eu/ema. Radius intends to appeal and immediately seek a re-examination of the CHMP opinion.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe