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EMA Validates Marketing Authorization Application for Abaloparatide-SC for the Treatment of Osteoporosis in Postmenopausal Women, NDA submission to FDA expected by the end of the first quarter of 2016

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Management Comment "The MAA for abaloparatide-SC is based on the results from the ACTIVE and ACTIVExtend trials, which demonstrated significant clinical benefit for postmenopausal women at risk of osteoporotic fracture," said Robert Ward, President and CEO of Radius Health. "The acceptance of our application for review by the EMA represents a significant step towards potentially bringing abaloparatide-SC to postmenopausal women with osteoporosis in Europe, and Radius looks forward to working with the EMA in the review procedure."
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Catalyst Date
Occurred on:
Mar 30, 2016
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Related Keywords Marketing Authorization, Ema, Fda, Osteoporosis, Abaloparatide-sc