Approval for PH-ILD inhalation drug 'Tyvaso' expected soon

The MFDS has completed evaluating the safety and effectiveness…Anterogen will distribute Tyvaso in South Korea

Tyvaso Inhalation Solution.

The approval of 'Tyvaso Inhalation Solution 0.6 mg/mL (treprostinil)' in South Korea is expected soon.

 

It is approved in the United States as the treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

 

According to industry sources on the 11th, the safety and effectiveness evaluation of Anterogen for the approval had been completed.

 

The completion of the safety and efficacy evaluation is followed by the NDA.

 

United Therapeutics’s Tyvaso is a treatment for patients with PH-ILD, and Anterogen has a domestic license.

 

In August last year, the Ministry of Food and Drug Safety (MFDS) designated the drug as the 14th Global Innovative products on Fast Track (GIFT).

 

Following the designation, Tyvaso has been under expedited review for approval.

 

For GIFT-designated products, the review duration is shortened by 25% (i.e., 120→90 working days), rolling review is applied, which enables review on prepared and available documents, close communication between the reviewer and the developing company, such as product briefing and explanation of supplementation, is offered, and various regulatory supports, including RA consulting for fast commercialization, are provided.

 

The company has applied for the efficacy and effectiveness of Tyvaso in PH-ILD, which is a fatal disease with no available treatments despite a survival rate of about 30% within three years of diagnosis.

 

Tyvaso first received approval from the U.S.

 

FDA in 2009 and received expanded indications for the first treatment of PH-ILD in 2021.

 

The approval was based on the INCREASE clinical trial data.

 

The trial was the largest, enrolling 326 patients with PH-ILD and the most comprehensive.

 

Tyvaso met the primary endpoint and significantly improved 6-minute walk distance (6MWD) results.

 

The treatment showed benefits in various major subgroups related to etiology, disease severity, age, sex, blood kinetics, and doses.

 

Improvements in the secondary endpoints included the reduction of NT-proBNP levels, a heart biomarker, the time to clinical worsening, the change in the highest 6MWD at week 12, and the change in the lowest 6MWD at week 15.