Amgen, Inc. (NASDAQ:AMGN) has reported that its Osteoporosis Drug will not be receiving approval any time soon after clinical trials triggered a negative heart safety risk signal.
Amgen’s new report about the negative heart safety risk signal identified during the osteoporosis drug trials means the drug will not receive approval in the U.S as the company had anticipated. The drug is called romosozumab though it would have been sold as Evenity and it had already satisfied the primary and secondary stages of late trials. Unfortunately, the firm identified that there was a high risk of serious heart problems and this had not been detected in earlier studies of the product.
“The efficacy results from this study comparing Evenity to an active control are robust. At the same time, the newly observed cardiovascular safety signal will have to be assessed as part of the overall benefit/risk profile for Evenity,” stated Amgen CEO Sean Harper.
What the new findings about the drug mean for Amgen
According to reports, Evenity was under consideration by the FDA and a marketing decision was due on July 19. However, the new information has prompted the U.S regulator to carry out an analysis of the safety data provided by the clinical trials. This means that Amgen does not expect the drug to be approved any time this year in the U.S. It is also not clear how much longer the approval process for the drug will take in light of the new findings.
Previous drug trials involving Evenity had been considered successful and so the new findings have definitely brought a dark cloud of uncertainty over the company’s expectations. The drug was expected to be a major growth driver for Amgen and thus the new report about the heart safety risks means the company’s plans will be derailed.
The company’s investors will most likely not be pleased with the news and this is expected to reflect in Amgen’s stock performance. Evenity was also scheduled for approval in Japan and Canada. The news about the heart safety risks will thus affect the review process in all the markets.
Amgen stock closed the latest trading session on Friday at $156.51 after tanking by 0.92 percent.
