Amgen Inc./UCB SA's investigational therapy for osteoporosis Evenity (romosozumab) could still bring in sales of more than half a billion dollars despite delays to market and concerns over its adverse event profile, say analysts as the product received a Complete Response Letter from the US FDA.
Hopes for a swift approval for the first-in-class sclerostin inhibitor died when a cardiovascular safety signal overshadowed positive efficacy data from the 4,000-patient ARCH study in May. The product was filed in 2016 largely on the basis of the somewhat mixed FRAME study (Also see " Amgen/UCB Poised For Osteoporosis Drug Filing On Back Of Mixed PhIII " - Scrip, 23 February, 2016