At a time when it seems new drugs are being approved (or conditionally approved) all the time, a recent clinical trial resulting in disapproval is certainly something to talk about. A clinical trial for Amgen’s new osteoperosis drug, Evenity, showed a negative heart safety signal, a sign that the US Food and Drug Administration will not approve the product to be marketed in the United States, this year.
Now, it is important to note that Evenity was, of course, already under consideration from the FDA with a new marketing decision expected to go public on July 19. However, questions regarding whether the drug increased heart safety risk caused US regulators to take a step back and analyze safety data from this new clinical trial.
According to Evercore ISI analyst Umer Raffat, “Amgen’s phase III update on bone drug [Evenity] just now is clearly negative and very surprising.” In a quick, Sunday evening note to clients, Raffat goes on to say, “At this point, we are taking out all [Evenity] sales from the model. Consensus has approximately $800 million peak for this drug… We suspect stock likely down approximately 3-4% on this.”
With all this in mind, then, Iris Loew-Friedrich notes: “We are working on understanding the observed cardiovascular safety signal and will continue to discuss these results with global regulators and experts in the field.” Loew-Friedrich, of course, is the chief medical officer of the Brussels-based drug maker UCB that is developing this drug in partnership with Amgen.
Effectively, the phase III study—the ARCH study—found the incidence of positively adjudicated cardiovascular serious adverse events in 12 months showed at 2.5 percent in the Evenity-treated group. This is compared to 1.9 percent of those patients treated with a generic osteoperosis drug called alendronate.
With that, Amgen shares fell about 2% in early Monday trading, after closing on Friday at $156.51.
While this is certainly unfortunate for Amgen, it could prove beneficial for Radius Health, who has also developed a competing osteoporosis drug, known as Tymlos. Radius had secured US approval for the drug in April. Shares of Radius seemed, on Monday, to follow suit, rising quickly by 17 percent in the early morning and then retreating to roughly 10 percent on the day.