- Food and Drug Administration staff appeared open to a narrow approval for Amgen's osteoporosis drug Evenity in documents published Monday which weighed the treatment's efficacy against safety concerns about its cardiovascular risk.
- The Bone, Reproductive and Urologic Drugs Advisory Committee will vote Wednesday on whether to recommend regulatory approval for the drug. This is Amgen's second review for Evenity after the agency issued a Complete Response Letter in July 2017 following increased levels of cardiovascular serious adverse events reported in clinical testing. These findings are the agency's "main concern and the reason for convening this advisory committee meeting," the briefing documents stated.
- A monthly injection, Evenity is up for approval for the treatment of osteoporosis in postmenopausal women at high risk of fracture. This is a narrower indication than the previous submission because of the cardiovascular safety signal and a label, if the drug is approved, could include a boxed safety warning.
The advisory committee, still at work despite the partial government shutdown, has a fine line to tread in evaluating Evenity (romosozumab).
Clinical trials have shown the drug is effective at reducing fracture risk in postmenopausal osteoporosis, and hip fractures are linked with mortality rates ranging between 10% and 58% in the year following the break.
However, Phase 3 trials also showed an increased risk of cardiovascular serious adverse events which carry their own morbidity and mortality risks, leading to the agency's 2017 rejection of the drug. Now, Amgen is targeting a narrower market in postmenopausal women with high risk of fracture.
An approved label could be even more limited than that, with briefing documents suggesting the reviewing committee consider if the drug should be OK'd only for women who also have low cardiovascular and cerebrovascular risk.
If approved, Evenity would fit in nicely alongside Amgen's Prolia (denosumab) franchise, which had total worldwide sales of $532 million in the third quarter of 2018, up 15% from a year ago. It could also provide fresh competition to Radius Health's Tymlos (abaloparatide), which had U.S. sales of just $27.6 million in the third quarter of 2018.
Jefferies sell-side analyst Michael Yee described the committee documents as "fairly benign versus expectations" in a Jan. 14 note to investors. Yee predicted a favorable panel vote and an approval in the first half of 2019.
Despite the ongoing government shutdown, parts of the FDA are still working — perhaps not at "business as usual" levels — but at least at a level that keeps the U.S. public safe from harm. This has required expansion of the excepted, unpaid work required of the agency's staff.
Drug reviews with already paid user fees will continue, the FDA has said, but new applications can't be accepted while funding remains lapsed.