Weekly drug pipeline calendar (July18 - July22)

BioPharm Insight US 發表了文章 · 2022/07/17 21:39

- $因塞特 (INCY.US)$：A supplemental new drug application (sNDA) and a marketing authorization application (MAA) for ruxolitinib cream as a treatment for vitiligo are under review at the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively. The Prescription Drug User Fee Act (PDUFA) target action date was extended to July 18, 2022.

Ruxolitinib cream has the potential to become the first product approved for repigmentation in vitiligo and would be a new therapeutic option for the millions of patients living with the disease today, pending regulatory decision.

- $Travere Therapeutic (TVTX.US)$ In February 2021, the Company announced that the ongoing pivotal Phase 3 DUPLEX Study of sparsentan in focal segmental glomerulosclerosis (FSGS) achieved its pre-specified interim FSGS partial remission of proteinuria endpoint (FPRE) with statistical significance.

The Company remains on-track to provide additional eGFR data from the ongoing DUPLEX Study to the FDA and to provide an update in mid-2022 on a potential NDA submission for accelerated approval of sparsentan for FSGS in the U.S., and with its partner Vifor Pharma, a combined IgAN and FSGS Marketing Authorisation Application (MAA) in Europe.