Daewoong to replace Astellas Irribow’s gap

Receives approval for Irricol Tab 5㎍ following 2.5㎍ approval…Pharmbio Korea completes bioequivalence testing for a generic version

Daewoong Pharmaceutical has filled the gap for Astellas Korea’s diarrhea-type irritable bowel syndrome treatment Irribow (ramosetron hydrochloride), which was discontinued in February this year.

 

The Ministry of Food and Drug Safety approved Daewoong Pharmaceutical's Irricol Tab 2.5㎍ (ramosetron hydrochloride) on the 20th.

 

This follows Daewoong receiving approval for the lower dose of Irricol Tab 5㎍ on May 31, filling the gap left by Irribow’s absence.

 

There are 23 items approved for ramosetron hydrochloride in Korea, but except for Irricol, all of them have indications only for the prevention of digestive symptoms (nausea, vomiting) caused by the administration of anticancer drugs.

 

Until last year, Irribow was the only ramosetron hydrochloride-based formulation for the treatment of diarrhea-predominant irritable bowel syndrome.

 

However, in November last year, Astellas announced its decision to withdraw the product from Korea for business reasons and reported the discontinuation of its supply in February of this year.

 

In the report, Astellas indicated Daewoong Pharmaceutical's Irricol as its substitute, stating, “It is unlikely that there will be a supply shortage for the treatment of IBS as sufficient alternative preparations have been identified for the treatment of patients.” According to MFDS’s production performance data, the import earnings of Irribow 5 µg and Irribow 2.5 µg in 2023 were USD 656,666 and USD 211,020, respectively.

 

Currently, only Daewoong Pharmaceutical is licensed to treat ramosetron hydrochloride-based irritable bowel syndrome, so it is expected to be able to secure performance in place of Astellas' Irribow.

 

Meanwhile, other than Daewoong Pharmaceutical, Pharmbio Korea is also known to have been conducting bioequivalence trials to develop a generic version of Irribow.

 

In April, Pharmbio Korea received approval for an open, randomized, two-arm, two-period, fasting, single-dose, oral, crossover trial in healthy adult male subjects to evaluate the bioequivalence of Pharmbio Korea’s PBK-G2401 with Astellas' RPBK-G2401.

 

PBK-G2401 is a generic version of Irribow, which is indicated for diarrhea-predominant irritable bowel syndrome.