Bukwang Pharmaceutical has decided to withdraw its license for Fra-Cut Inj., a generic version of Mitsubishi Tanabe Pharma’s amyotrophic lateral sclerosis (ALS) treatment, Radicut (edaravone).

That comes a year after the Ministry of Food and Drug Safety approved the drug.

The ministry announced Monday Bukwang’s withdrawal of Fra-Cut.

Fra-Cut is a generic version of edaravone approved by the ministry on May 13, 2022. It is used to slow the progression of functional disability caused by ALS, also known as Lou Gehrig's disease.

Bukwang entered the ALS market as the first and only Korean company to develop a generic for edaravone but withdrew from the market after a year.

Bukwang’s competitiveness has been questioned since the development of Fra-Cut. That's because Mitsubishi Tanabe improved the formulation of the original product by turning the intravenous Radicut into an oral suspension, MT-1186.

In Korea, too, a phase 3b clinical trial of the oral suspension is going on after winning approval from the ministry in March last year for completion around next May.

Worse yet, the market outlook for Fra-Cut was not promising, as there are only about 3,000 people with ALS in Korea, and the annual sales volume of the original product, Radicut, is also small.

Radicut's annual revenue is rising but stood at only 2.25 billion won ($1.74 million) in 2022, according to IQVIA.

However, even though edaravone was designated as an orphan drug in Korea, Mitsubishi Tanabe has strategically abandoned Radicut’s reimbursement, so there is a large unmet need for this part of the market.

Bukwang also recognized this unmet need and attempted to get benefits as soon as it won approval. However, Fra-Cut failed to receive the benefit until it decided to withdraw its license.