FDA requires Belviq to be withdrawn from its US market due to cancer risks. Eisai
The FDA has requested that Eisai Co. Ltd. voluntarily withdraw the obesity pills Belviq and Belviq XR (lorcaserin) from the US market because of an increased risk of cancer. The announcement on 13 February comes after Eisai demonstrated the cardiovascular safety of Belviq in an outcomes trial, but that same trial showed an increased risk of cancer occurrence.
The FDA issued an alert in January notifying the public that it was assessing the safety of Belviq for a potential increased risk of cancer. In the 12,000-patient CAMELLIA-TIMI 61 trial, Eisai showed Belviq did not increase major cardiovascular events compared to placebo, but the drug did not improve cardiovascular outcomes either. At the time the data was first released in mid-2018, Eisai did not highlight cancer as a safety signal. The FDA had required the cardiovascular outcomes trial (CVOT) as a post-approval commitment.
Comment: Belviq was withdrawn from the EU application in 2013.
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