Amgen and UCB re-file for Evenity approval in USA
US biotech major Amgen (Nasdaq: AMGN) and Belgian pharma company UCB (Euronext Brussels: UCB) have resubmitted their Biologics License Application (BLA) to the US Food and Drug Administration for Evenity (romosozumab),
The drug is an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture. The original Evenity BLA received a Complete Response Letter from the FDA a year ago, when the agency asked the companies to include in their application efficacy and safety data from the Phase III ARCH (Active-contRolled fraCture study in postmenopausal women with osteoporosis at High risk of fracture) trial, which compared Evenity to Merck & Co’s Fosamax(alendronate sodium). This study saw observation of a cardiovascular safety signal.
Market reaction to the news was muted, with Amgen closed up 0.49% at $194.09 yesterday, while UCB was down around 1% at 69.20 euros at lunch time today.
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