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Takeda's Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda's Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care.

Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera

OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide. Rusfertide is an investigational, first-in-class hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera (PV). The FDA has set a Prescription Drug User Fee Act.

Positive Phase 3 Data Demonstrate Potential for ENTYVIO® (vedolizumab) to Address Treatment Gap for Children and Adolescents with Moderate to Severe Ulcerative Colitis

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced positive data from the pivotal Phase 3 KEPLER trial, which demonstrated that ENTYVIO® (vedolizumab) can offer the possibility of clinical remission for patients ages 2 and older with moderately to severely active ulcerative colitis (UC), a chronic inflammatory disease of the gastrointestinal tract and one of the two most common types of inflammatory bowel disease.1,2 The results, presented at the 21st C.

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda's Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--FDA Accepts New Drug Application and Grants Priority Review for Takeda's Oveporexton as a Potential First-in-Class Therapy for Narcolepsy Type 1.