When Eisai picked up struggling obesity med Belviq in 2016, it knew it would have its work cut out for it in a chronically underperforming market. But now, after years of struggle, the drug's journey may be at an end.
At the FDA's request, Eisai will pull Belviq and Belviq XR off U.S. shelves. The move comes after the FDA flagged a higher rate of cancer diagnoses in patients treated with the drug as part of a postmarket study evaluating cardiovascular risks.
In January, the administration warned consumers that a more-than-four-year study, requested after Belviq's approval in 2012, showed a possible link to increased cancer risks in patients with either an established cardiovascular disease or multiple risk factors.
In that study, dubbed Camellia-Timi-61, 7.7% of trial patients treated with Belviq were diagnosed with cancer compared with 7.1% of patients in the placebo arm. The FDA requested Eisai pull the drug, arguing the "risks of (Belviq) outweigh its benefits based on our completed review of results from a randomized clinical trial assessing safety."
Eisai is currently in discussions with global distributors to facilitate the withdrawal, the drugmaker said in a statement Thursday.