Belviq was withdrawn voluntarily by Ildong

Discontinued domestic sales preemptively, In consultation with the MFDS

Ildong Pharmaceuticals voluntarily discontinued the sale of its obesity drug, Belviq.

 

In the United States, it was advised to withdrawal of permission because of the risk of developing cancer, and it has preemptively discontinued sales in Korea.

 

According to the industry on the 14th, Ildong Pharmaceutical decided to stop selling Belviq in Korea.

 

Ildong Pharmaceutical said, “The FDA recommended discontinuing sales in the US because of the increased incidence of cancer,and we are proactively discontinuing Belviq's sales and are discussing with MFDS for further actions”.

 

In this regard, the US FDA recommended Belviq’s withdrawal.

 

Due to the increased risk of developing cancer, and has asked Belgian developer Belviq’s developer, Eisai to withdraw of the market.

 

The FDA said last month that the results of Belviq's safety assessment trials indicate a new increased risk of cancer during the trial.

 

In a clinical trial involving 12,000 patients in a five-year trial to evaluate heart-related problems by Eisai, patients taking Lorcaserin(generic for Belviq) were more likely to be diagnosed with cancer than those taking placebo.

 

.In Korea, the official position of the Food and Drug Administration has not been determined in relation to Belviq's sale or discontinuation of prescriptions

 

.Although the MFDS has not decided, Ildong plans to discontinue its sales and follow up with safety verification

 

.Belviq was the drug that had been expected to be a safe obesity drug since its introduction to the market

 

.Belviq, which was domestically licensed in February 2015, is a new drug approved for weight control by the FDA in 13 years

 

.Belviq is a drug that selectively acts on the serotonin receptor, a neurotransmitter that regulates appetite and emotions, suppressing appetite and improving satiety

 

.According to drug research institution IQVIA, Belviq ranked No.1 in obesity treatments with 2018 sales of ₩9.8 billion in Korea

 

.After the emergence of Saxenda in the second quarter of 2018, it was handed over to the top spot for obesity treatment, but it was still regarded as a highly preferred obesity treatment

 

.Cumulative sales for the third quarter of last year stood at ₩6.6 billion

 

.However, the sale was put into the worst crisis due to this withdrawal

 

.Ildong Pharmaceuticals official said, “We will implement further measures as soon as consultation with MFDS is completed, and will faithfully do all measures with the patient's health first”.