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Eisai Inc submits sNDA with US FDA to update the labeling of anti-obesity agent BELVIQ (lorcaserin HCl).

M2 EQUITYBITES-February 26, 2019-Eisai Inc submits sNDA with US FDA to update the labeling of anti-obesity agent BELVIQ (lorcaserin HCl)


Human health care company Eisai Inc said on Monday that it has successfully filed its supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) to potentially update the label of the anti-obesity agent BELVIQ from the CAMELLIA-TIMI 61 clinical trial.

According to the company, BELVIQ/BELVIQ XR is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).

The addition of this data from the company's CAMELLIA-TIMI 61 clinical trial has the potential for a revision to the product label's Indications and Usage, removing the Limitation of Use related to the effect of BELVIQ on CV morbidity and mortality.

In conjunction, the company's CAMELLIA-TIMI 61 is a clinical trial of BELVIQ in 12,000 overweight and obese patients with cardiovascular (CV) disease and/or multiple CV risk factors including type 2 diabetes mellitus (T2DM). CAMELLIA-TIMI 61 met its primary safety objective, finding that long-term treatment with BELVIQ did not increase the incidence of major adverse cardiovascular events (MACE) in overweight and obese patients at high risk for a CV event.

In conjunction, the company's CAMELLIA (Cardiovascular And Metabolic Effects of Lorcaserin In Overweight And Obese Patients) TIMI 61 study was the largest double-blind, placebo-controlled, parallel-group Phase IIIB/IV study in 12,000 patients at high risk for a CV event underwent randomisation.

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Publication:M2 EquityBites (EQB)
Date:Feb 26, 2019
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