Once-daily formulation of Belviq under review by FDA.
+ Regulatory
Jamie Barrand | Dec 5, 2015

Once-daily formulation of Belviq under review by FDA

Obesity is a global epidemic. Studies have shown that more than 1.4 billion adults across the globe are overweight, and that 500 million of those people are considered obese. For people who are ready to try a pharmaceutical weight loss route, a new therapy may soon be available.

Tokyo, Japan-based Eisai Co. Ltd.'s New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a once-daily formulation of Belviq (lorcaserin hydrochloride) has been accepted for review.

Next, the FDA will assess the application to determine whether or not drug approval will move forward.

A twice-daily formulation of Belviq was OK'd by the FDA in June 2012.

Belviq is an oral medication that controls the patient's food intake by selectively activating the brain's serotonin 2C receptors. This causes patients to eat less because they feel full sooner.

Clinical studies revealed some adverse effects, including headache, dizziness, nausea, fatigue, dry mouth and constipation.

Belviq will also be studied for possible cardiovascular outcomes. There are 12,000 patients involved in the study, some in the U.S. Results from that study are expected sometime in 2018.

Should this formulation be approved, Belviq will be marketed in the U.S. exclusively by Eisai.

More information about Belviq can be found online at www.belviq.com.

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+ Eisai

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