BioPharma, Policy

Eisai to pull obesity drug after post-marketing study reveals increased cancer risk

The voluntary withdrawal was in response to an FDA request. Eisai said its interpretation of the data differed from the agency's, but the drug's original developer had called off pursuit of European approval when regulators there pointed to potential tumor risk from long-term use.

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A weight-loss drug on the market for eight years will soon disappear from pharmacy shelves after a post-marketing study revealed an increased risk of cancers among patients taking it.

On Thursday, the Food and Drug Administration requested that Tokyo-based drugmaker Eisai voluntarily withdraw the drug Belviq (lorcaserin) and its extended-release formulation, Belviq XR, from the market. Eisai said the same day that it would voluntarily withdraw the drug from the U.S. market. The FDA is also advising patients to stop taking it and to seek alternative weight-loss treatments.

Shares of Eisai were down 1.4% on the Tokyo Stock Exchange when Japanese markets closed Friday.

The FDA’s move stemmed from a review of data from a placebo-controlled Phase IV study of Belviq in 12,000 patients that the agency had required its original developer, San Diego-based Arena Pharmaceuticals, to conduct in order to assess the drug’s risk of causing heart attacks after its 2012 approval. Eisai acquired global development and marketing rights to the drug in 2017.

Data from the study did not show any meaningful difference in cardiovascular risk between the two study arms. However, it did show that 7.7% of patients taking the drug had a diagnosis with a range of cancer types, including pancreatic, lung and colorectal, compared with 7.1% of those in the placebo arm. While there was no apparent difference in incidence of cancers between the two arms during the first few months of treatment, the imbalance increased as patients stayed on the drug for longer periods.

Eisai said its interpretation of the data from the trial differed from the FDA’s and that it continued to regard the drug as having a positive risk-benefit profile.

Nevertheless, in contrast with the FDA approving the drug and requiring the post-marketing studies, Arena withdrew its application for European Medicines Agency approval of the drug in 2013. The EMA’s Committee for Medicinal Products for Human Use had expressed concerns about the potential risk of tumors from long-term use of the drug, based on lab tests, as well as heart valve and psychiatric problems. As such, the CHMP stated provisionally that the EMA would not approve the drug, leading to its withdrawal from consideration.

In its 2019 earnings, Eisai reported that Belviq had sales of $28.1 million in the U.S. for the year. Global sales of the drug were about $42 million.

Photo: Oko_SwanOmurphy, Getty Images

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