The Ministry of Food and Drug Safety recently recommended Ildong Pharmaceutical to pull obesity drug Belviq off the shelves voluntarily, citing cancer risks. However, the regulator has not received any cancer cases in postmarketing surveillance (PMS).

The ministry’s push for the recall of Belviq (ingredient: lorcaserin) was based on the U.S. Food and Drug Administration’s request for Eisai Pharmaceutical, the Japanese maker of Belviq, to withdraw Belviq from the market. Ildong is the distributor of Belviq in Korea.

“After the FDA’s issuance of the safety letter in January, the food and drug safety ministry also requested Ildong Pharmaceutical to submit data of the CAMELLIA-TIMI 61 trial. The FDA recommended the voluntary recall of Belviq even before we received data,” a ministry official said. “So, the food and drug ministry requested Ildong to discontinue the sale of the drug and recall it. The company accepted the request and decided to withdraw it.”

The official’s comment means that the government did not analyze any clinical data or collect expert opinions and went ahead to copy the FDA’s action to push Ildong to recall Belviq.

To a question of whether the ministry found any local cancer case in a PMS of Belviq, the ministry official said it did not.

A drug company is obligated to conduct a PMS on a pharmaceutical product, every six months for the first two years and annually after the two years, to report adverse reactions and serious adverse events to the regulator.

“If Ildong Pharmaceutical submits the data we requested, we will review it. We will determine a follow-up measure after the data review. Until now, we have not made any decision over the cancellation of the permit,” the official added.

Ildong Pharmaceutical said it decided to accept the regulator’s recommendation and recall the obesity drug, which landed on the Korean market five years ago. Since the market release in 2015, Belviq’s accumulated sales exceeded 50 billion won ($41.9 million).

To import Belviq in 2012, Ildong clinched an exclusive sales deal with Arena GmbH, a subsidiary of Arena Pharmaceuticals. Ildong offered Arena GmbH $5 million for the upfront payment and agreed to pay another $3 million for milestone payment upon the regulatory approval for Belviq.

After the regulator gave the nod for Belviq in 2015, Ildong paid $3 million to Arena GmbH as agreed and decided to receive Belviq at a price equivalent to 35 percent of the annual net sales of Belviq in Korea.

As Ildong paid all the costs for approval, marketing, sales, and workforce for Belviq in Korea, the 50 billion won accumulated sales from Belviq has virtually been spent as an initial investment cost, observers said.

In such a situation, the food and drug safety ministry’s decision to kick the drug out just because the FDA did so was too hasty, they added.

kym@docdocdoc.co.kr

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