Expectations for Evenity (romosozumab) are modest, and the rejection by the EMA is a “minor setback” for Amgen, according to RBC Capital Markets analyst Kennen MacKay.
Still, the decision reflects the struggles Amgen and UCB have had in advancing Evenity, which was initially rejected by the FDA before securing an approval for the treatment of osteoporosis in April.
Osteoporosis affects millions of women in the U.S. and Europe, making it a potentially lucrative market. But signs Evenity increased the risk of serious heart events led the FDA to limit its approval to only postmenopausal women at high risk of fractures and to recommend doctors limit use to 12 months.
As a result, Wall Street analysts don’t expect the drug to sell particularly quickly. Earnings results from the first three months of 2019 didn’t break out Evenity sales in particular, but included the drug in a line item category that netted Amgen just $23 million in the U.S.
European regulators also focused on the drug’s heart risk, noting too that more patients aged over 75 years died when given the medicine.
“As it was unclear why the medicine appeared to increase the risk of heart and circulatory problems, and there was no obvious group of patients in whom the risk of these was lower, measures to reduce the risk could not readily be put in place,” the agency wrote in explaining its decision.
A rejection by the European Commission would mean less opportunity for Amgen and UCB to boost sales across new markets. While the companies intend to request a re-examination, the EMA’s past decision-making on Radius Health’s rival osteoporosis drug doesn’t inspire much confidence.
In 2018, the agency also recommended against approving Radius’ drug, sold as Tymlos (abaloparatide) in the U.S. The biotech requested a second review, but the EMA again refused to recommend an OK.
RBC’s MacKay, though, sees some potential for a reversal.
“Given the favorable regulatory reviews already conducted in the U.S. and Japan, we see a possibility that the companies may be able to successfully argue their case for approval, potentially with a more restrictive label,” the analyst wrote.
Amgen sales were little moved in Friday trading.
