- A Food and Drug Administration advisory committee voted 18-1 on Wednesday to recommend approval for Amgen and UCB's Evenity as a treatment for postmenopausal women with osteoporosis at high risk for fracture.
- The vote marks a step forward in the companies' second attempt to win regulatory approval, after the drug was previously turned down by the FDA in 2017. While the Bone, Reproductive and Urologic Drugs Advisory Committee recommended approval by a wide margin, it also emphasized the need for post-marketing follow-up.
- Briefing documents from FDA staff, published Monday, probed the balance between the drug's benefit and the increased levels of cardiovascular serious adverse events reported in clinical testing. While the FDA does not have to follow the committee's recommendation, it typically does.
The clinical benefit for treating osteoporosis are clear. After an osteoporotic fracture, a woman is five times more likely to suffer another fracture within the first year, and her risk remains elevated over time if untreated.
However, as with many conditions, treatment can bring side effects, and that was one of the main concerns surrounding Evenity (romosozumab).
The agency issued a Complete Response Letter for the drug in 2017, leading Amgen and its partner UCB to work on ways to get their drug to market despite an increased risk of cardiovascular events seen in trials.
The companies narrowed the drug's intended market to postmenopausal women with a high risk of fracture. Briefing documents suggested the FDA advisory group look at the potential of reducing a potential label even further to only women with low cardiovascular and cerebrovascular risk.
Amgen has already proposed Evenity carry a boxed warning, and the committee's only caveat appears to be a request for post-marketing study.
Michael Yee, an equity analyst at Jefferies, believes that even with a boxed warning, Evenity could still pull in more than $500 million in peak annual global sales. Evenity was approved in Japan last week, where development was led by a joint venture between Amgen and Astellas Pharma.
Evenity will be entering a changing market. Lilly's Forteo (teriparatide), which earned revenues of $1.1 billion in the first nine months of 2018, lost its formulation patent last December. A use patent will expire this August in the U.S. and Europe.
Pfenex, a San Diego, California-based biotech, has submitted an application for a drug considered to be therapeutically equivalent to Forteo and, in Europe, two biosimilars of Lilly's drug are already approved.
Following patent expiries, Lilly expects a rapid and severe decline in revenue in the U.S., and a smaller decline in Europe.
The presence of lower-cost competition to Forteo could also put pressure on Radius Health's Tymlos (abaloparatide) and may impact uptake of Evenity, if approved.
While Tymlos sales have been modest so far, Radius has predicted 2019 sales of between $155 million to $175 million, which would make for a 69% increase year-on-year, assuming just one Forteo generic entry in 2019.