Japan-based Eisai Pharmaceuticals pulled its anti-obesity drug Belviq from the U.S. market due to reports that it is associated with an increase in the incidence of cancer in users. The U.S. Food and Drug Administration made a formal request for the company to take Belviq and Belviq XR off the market last week.
Approval based on Study
Approved back in 2012, the agency required the company to conduct a randomized, double-blind, placebo-controlled clinical trial known as CAMELLA-TIMI 61 to evaluate the risk of cardiovascular problems. The study revealed that more patients taking lorcaserin (Belviq) were actually diagnosed with cancer compared to those taking the placebo reported Korea Biomedical News. The study included 12,000 patients over five years.
Eisai Doesn’t Agree
Eisai didn’t agree with the FDA interpretation of the clinical trial and although of course will comply with the FDA have stated, “We assess that Belviq and Belviq XR continue to have a positive benefit-risk profile in the patient population for which they are indicated.”
A Stir in Korea
The decision could cause a stir in Korea among patients and the drug’s distributor Ildong Pharmaceutical as the Korean Ministry of Food and Drug Safety may follow the FDA’s decision and pull the drug from the local market.
According to the drug market research arm of IQVIA, Belviq ranked first in the local obesity market in 2018 with total sales of $8.2 million. The drug has since lost its position to Novo Nordisk’s Saxenda which undoubtedly will benefit from this news.