If the MFDS followed the EMA instead of the FDA for Belviq

The EMA rejected approval in 2013 due to tumor induction

The US FDA Approved June 2012, In Korea, all product licenses were granted in February 2015

By 2018, cumulative sales up to 50 billion, cancer concerns labels only started last year

Appetite suppressant

At the time of approving Belviq, banned by the MFDS on the 14th, it would be regrettable that it had not been approved in accordance with the European EMA's decision.

 

The European EMA disagreed with the approval due to side effects from animal testing, and the developer voluntarily withdrew the application.

 

The US FDA, on the other hand, approved it in June 2012, subject to post-marketing studies on cardiovascular risk.

 

Belviq was licensed in Korea through Ildong, an importer, in February 2015.

 

In April of last year, Belviq XR was approved.

 

Belviq was designated for re-examination at the time of domestic approval and was ordered for post-marketing investigation for six years from February 2015 to February 2021.

 

Developed by the US Arena Pharmaceuticals, Eisai owns all rights in the United States, and Arena owns all rights in Europe and Asia.

 

In 2012, Ildong gained copyright through a contract with Arena.

 

The MFDS issued an order to suspend sales and recall in Korea on the 15th, referring to the US FDA's withdrawal order for Lorcaserin.

 

U.S.

 

distributor Eisai is reportedly withdrawing from the United States.

 

As a result, Ildong Pharmaceutical, a domestic seller, is expected to exit the market by returning the permit.

 

All items on the market will be recovered.

 

Belviq's problem is the risk of developing cancer.

 

The U.S.

 

FDA reviewed CAMELLIA-TIMI 61, a clinical trial conducted by Eisai, and concluded that the longer the treatment period, the greater the incidence of cancer compared to the placebo group.

 

In the past five years, over 12,000 patients with high cardiovascular risk were overweight or obese, and 520 cases of primary cancer were diagnosed in 462 patients (7.7%) in the Lorcaserin group and 470 cases, 423 patients (7.1%) in the placebo group.

 

In particular, the incidence of some types of cancer, such as pancreatic cancer, colorectal cancer, and lung cancer, was higher in the Lorcaserin-administered group than in the placebo-administered group.

 

In fact, Belviq's issue was whether it was safe in cardiovascular disease.

 

This is because the obese drug Sibutramine has been withdrawn from the market due to side effects of 'cardiovascular disease'.

 

Eisai also conducted a post-marketing investigation with an emphasis on cardiovascular safety.

 

As a result of the 'CAMELLIA-TIMI 61' clinical trial, the annual incidence of cardiovascular events (MACE) was 2.0% in the Belviq group (Lorcaserin 10mg, twice daily), and 2.1% in the placebo group.

 

The risk of adverse effects on the cardiovascular system was negligible.

 

But because of the unexpected side effects of developing cancer, Belviq eventually got stuck.

 

Earlier, the European EMA rejected Belvik's approval in an animal trial in late January 2013 for side effects such as tumor induction, heart valve disorders and mental illness.

 

Although it was not related to the human test, it was the conclusion that the results of animal experiments were actively reviewed.

 

On January 16, the FDA announced that it would review the issue of cancer, and the MFDS announced that it would distribute safety letters to review domestic and international permits and usage.

 

In the meantime, information on cancer incidence increased in animal experiments is reflected in the permit, and the association with humans is unknown.

 

However, the fact that the incidence of cancer has increased in animal experiments is not included in the Belviq permit, which was granted in February 2015, but in the Belviq XR, which was granted last year.

 

This is why the MFDS has been actively aware of the issue at the time of its approval.

 

If the agency had listened to the European EMA decision and not the US FDA, the risky drug would not have been used in the patient.

 

Belviq was launched in Korea in the first quarter of 2015 and recorded sales of ₩13.6 billion in IQVIA, ₩15 billion in 2016, ₩12.2 billion in 2017, and ₩9.8 billion in 2018.

 

While selling more than ₩50 billion, no measures were taken in Korea.