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Eisai agrees to pull obesity drug Belviq after safety alert

Weight-loss drug linked to increased risk of cancer

Eisai

Eisai has moved swiftly to comply with an FDA request to pull its obesity drug Belviq off the market after it was linked to an increased risk of cancer.

The decision to withdraw Belviq (lorcaserin) and once-daily line extension Belviq XR from the US market stems from a clinical trial that was conducted at the request of the FDA following the product’s first approval in 2012.

The study was intended to check whether the drug was associated with any cardiovascular safety issues, but follow-up revealed “several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal and lung”.

Cancer rates were 7.7% for patients taking Belviq compared with 7.1% for those taking placebo, and while the difference isn’t huge Eisai has agreed to follow the FDA’s advice, despite disagreeing with the conclusions.

The company said in a statement that it still believes Belviq’s benefits in weight loss outweigh its risks, but “respects the FDA's decision and is working closely with the agency on the withdrawal process”.

Patients prescribed the selective serotonin 5-HT2C receptor agonist have been advised to stop taking it and to dispose of unused medication, and discuss alternative weight-loss options with their doctors.

In 2010, the FDA rejected the first marketing application for the drug, filed by its original developer, Arena Pharmaceuticals, asking for more details on cancer observed in animal studies.

Belviq was never launched in Europe because Arena withdrew its marketing application amid resistance from the EMA’s Committee for Medicinal Products for Human Use (CHMP), which was uncomfortable with the safety data.

Eisai bought global rights to the Belviq range from Arena for $23m in 2017, after acting as its exclusive distributor since launch, in the hope of kickstarting what had been lacklustre sales for the drug.

Another $26m was tied to commercial objectives, with the bulk of that only due if sales of the product topped $250m a year.

The product has never come anywhere near that objective – sales in the first nine months of Eisai’s current fiscal year came in at only $27m – which likely explains why the company hasn’t dug its heels in over the FDA request.

Article by
Phil Taylor

14th February 2020

From: Regulatory

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