New PAH drug Winrevair to land in KOR next year
By Eo, Yun-Ho | translator Alice Kang
24.12.13 05:22:30
°¡³ª´Ù¶ó
0
Completes 2nd approval-reimbursement linkage evaluation
Demonstrated efficacy through the STELLAR study
According to industry sources, MSD Korea's Winrevair (sotatercept), the world's first symptomatic treatment for pulmonary arterial hypertension, recently passed the second approval-reimbursement linkage evaluations. The drug¡¯s formal approval is expected in 2025.
Winrevair had been designated as an orphan drug by the Ministry of Food and Drug Safety in January, then designated as a Global Innovative products on Fast Track (GIFT) in April this year.
In March, the US FDA approved Winrevair for the treatment of pulmonary arterial hypertension as a subcutaneous injectio
Eo, Yun-Ho(unkindfish@dailypharm.com)
If you want to see the full article, please JOIN US (click)