Mezzion Pharma to try again for US FDA approval of drug

South Korea's Mezzion Pharma will seek to get the oral medicine Udenafil to treat side effects from heart surgery, planning to clinical trials in the final Phase 3 again. 

The company on Tuesday said it will submit this year a Phase 3 investigational new drug application for udenafil to the U.S. Food and Drug Administration. Clinical trials are expected to start in the first half of next year, around a year after Mezzion Pharma's failed bid in March this year to secure statistical significance to prove the drug's effectiveness.

Iquvia of the US is the contract research organization for the resubmission bid.

Mezzion Pharma is developing Udenafil, which treats erectile dysfunction, for use in improving breathing and exercise capacity in patients undergoing Fontan surgery for congenital heart defects. Phase 3 clinical trials on 400 people failed to objectively prove the drug's efficiency.

On its unsuccessful bid, Mezzion Pharma said, "We failed to prove statistical significance because the trials included many 'super Fontan patients' who originally had excellent exercise capacity even without taking medicine."

The company plans additional Phase 3 clinical trials on 300 patients excluding super Fontan ones, and this process is expected to take at least a year since around two years was needed for clinical trials on 400 people.

Write to Jae-Young Han at jyhan@hankyung.com