Amgen is pricing its newly approved osteoporosis drug Evenity on par with Radius Health’s competitor anabolic Tymlos. But its cardiovascular risk has already drawn outcry from a consumer activist group, and at least one analyst isn’t so enthusiastic about its black box label and seemingly inferior nonvertebral fracture benefit.

Given as a once-monthly therapy, Evenity comes with a list price of $1,825 per dose, or $21,900 for a year. And a year is as far as Evenity can get, as the FDA doesn’t allow its use beyond that point due to decreased bone-forming benefit.

Amgen, in a Tuesday statement, said the price is "in line with Amgen's focus on innovation and commitment to responsible pricing," and that it has taken into account the physical and financial burden of osteoporosis-related fractures.

The annual price is about the same as Tymlos’ but represents a discount of about 50% off Eli Lilly’s rival drug Forteo, which could soon face generic competition. However, because the Radius and Lilly drugs can be given 18 months or 24 months, Amgen calculates Evenity’s full-course price as 34% to 74% lower than its peers.

All three drugs are known as anabolic, which means they can build bone mass. Their predecessors, including bisphosphonates such as Merck & Co.’s Fosamax and Amgen’s own antibody drug Prolia, can prevent bone loss but don’t stimulate bone growth. 

Last Tuesday, the FDA approved Evenity to treat osteoporosis in post-menopausal women at high risk of fracture. But the approval comes with a boxed warning of an increased risk of cardiovascular events that researchers noticed in one of Evenity’s two phase 3 studies, and the FDA forbids the drug’s use in patients who have had a heart attack or stroke within the previous year. The CV signal led to an initial FDA rejection in 2017, even though another larger trial didn’t spot the same problem.

Now, the agency is demanding a postmarketing analysis that focuses on Evenity’s CV safety, but one consumer activist group isn’t so happy about the approval to begin with.

"Women may be better off taking a cheaper generic version of an existing drug than gambling on Evenity," National Women’s Health Network said in a statement last week, noting that post-approval studies "are not always completed in a timely fashion, if at all."

Even without the loud protest, CV risks could seriously hamper Evenity’s uptake, according to SVB Leerink analyst Geoffrey Porges.

"Given the elderly nature of the intended population, and the known increase in background cardiovascular risk after menopause, the black box warning seems likely to discourage many of the very osteoporotic patients who would otherwise be eligible for treatment," Porges said, noting that 55% to 60% of patients in the phase 3 Evenity trials were on background heart medications.

It’s not just Evenity’s safety that has come under scrutiny. In his Wednesday note to clients, Porges recognized Evenity’s seemingly superior bone-building effect over Tymlos and Forteo. But in the phase 3 studies, the increase in bone mineral density "did not translate into reduced fracture risk for non-vertebral fractures (e.g., hip and wrist fractures) which are the most consequential complications of osteoporosis."

In separate studies that were not intended for direct comparison, Tymlos and Forteo reduced risks of nonvertebral fractures against placebo by 43% and 53%, respectively. But Evenity cut risks by just 25%, a figure that was not statistically significant as shown in the 7,180-patient Frame study pitting the Amgen drug against placebo.

"Evenity’s black box label and inferior nonvertebral fracture benefit are likely to relegate the drug to patients that have failed, or have stopped responding to the benefit from parathyroid hormone agents or Prolia," Porges said.

Evenity does boast a convenience edge over the Radius and Lilly drugs. It is a monthly injection versus daily dosing for its two anabolic rivals.

Jefferies analyst Michael Yee previously predicted Evenity peak sales of over $500 million. SVB Leerink’s Porges, for his part, projected the drug could peak at $700 million in total unadjusted sales.

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