Eisai will pull obesity drug Belviq off U.S. shelves after FDA flags cancer risks
Eisai acquired sole rights to Belviq in a cash sale with Arena in 2017. (Eisai)
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.
Building a Flexible, Challenge Resistant and Patient Centric Clinical Supply Chain
The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. In this webinar, learn the benefits of utilizing demand-led supply and direct-to-patient distribution models in the clinical supply chain, as well as how they can be used to both improve flexibility and better align with patient needs. Register today!
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.