SGLT-2 monotherapy 'Suglat' set to withdraw from KOR

Has reported to the MFDS that it will stop distribution in August

Marks a third case, following Steglatro and Forxiga

Astellas Korea

The SGLT-2 inhibitor 'Suglat tab 50 mg (Ipragliflozin L-Proline),' which is used as monotherapy, will no longer be available in the market in South Korea.

 

Three SGLT-2 monotherapies that were imported will be withdrawn from the Korean market, as Steglatro and Forxiga are set to be withdrawn.

 

According to the Ministry of Food and Drug Safety (MFDS) on April 10th, Astellas Korea has reported that the company will stop distributing Suglat as of August 15th due to a business decision.

 

Astellas explained, “We have confirmed that there are enough alternative agents available for the treatment of patients.

 

Therefore, the likelihood of a supply shortage for the treatment of type 2 diabetes is likely low.” The company added that additional measures or plans after they stop distribution are unnecessary.

 

Suglat is a diabetes treatment that was co-developed by Japan’s Astellas and Kotobuki Pharmaceutical.

 

It was launched in Korea in 2015.

 

Handok was previously responsible for co-distribution with Astellas, following Daewoong Pharmaceutical.

 

Three SGLT-2 monotherapy items are to be withdrawn from the Korea market.

 

Last year, AstraZeneca decided to stop distributing Forxiga (dapagliflozin propanediol) in the second half of this year and recently cancelled the product approval.

 

MSD Korea reported to the MFDS in March that the company will distribute Steglatro Tab 5 mg (ertugliflozin L-pyroglutamic) until May.

 

The decision was made due to decreased market demand.

 

Suglat’s withdrawal from the Korean market appears to be due to below-expected sales, with outpatient prescription sales of KRW 4 billion, according to UBIST last year.

 

The company may have determined that imported new drugs might not be able to compete against the release of Forxiga generics in April of last year.

 

The remaining imported SGLT-2 monotherapy is Boehringer Ingelheim Korea’s Jardiance Tab (empagliflozin).

 

SGLT-2 monotherapy developed in Korea is Daewoong Pharmaceutical’s 'Envlo tab (enavogliflozin),' launched last year.

 

As imported new drugs are to be withdrawal, Envlo will have an opportunity to expand its share in the market.

 

Boehringer Ingelheim aims expand the reimbursement of Jardiance to kidney disease treatment to fill the gap left by Forxiga.

 

According to the report on the SGLT-2 monotherapy prescription performance by UBIST last year, Jardiance ranked first with KRW 58.1 billion, followed by Forxiga with KRW 55.5 billion, Suglat with KRW 4 billion, Envlo with KRW 3.7 billion, and Steglatro with KRW 11.1 billion.

 

Attention is drawn to the impact of the withdrawal of three imported original items from the Korean market on future competition.