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The US FDA has accepted the NDA & granted priority review to zasocitinib (TAK-279) for the treatment of adults with mod. to sev. plaque psoriasis (PsO), with the PDUFA target action date in Q1’27. MAA is under EMA’s review, with further global filings planned
NDA was supported by extensive data incl. global P-III (Latitude PsO 3001 & PsO 3002) studies, which met their 1 & 2EPs, plus LATITUDE PsO 3003, an open-label study, to assess zasocitinib’s long-term safety, tolerability & efficacy Â
TAK-279 showed significant skin clearance & symptom relief, with ~70% pts achieving clear/almost clear skin (sPGA 0/1) by Wk. 16, rapid & durable clearance from Wk. 4 through Wk. 52, & strong efficacy at across hard-to-treat & high-impact sites incl. the scalp, nails, palms & soles
Ref: Businesswire | Image: Takeda | Press Release
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The post The US FDA Grants Priority Review to Takeda’s Zasocitinib in Plaque Psoriasis appeared first on PharmaShots.
The US FDA Grants Priority Review to Takeda’s Zasocitinib in Plaque Psoriasis | PharmaVoice