Takeda Pharm Stock Price, News & Analysis

Takeda announced the U.S. FDA's acceptance of its Biologics License Application (BLA) resubmission for the investigational subcutaneous administration of Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). This resubmission addresses FDA feedback from a 2019 Complete Response Letter (CRL). The resubmission includes additional data on the SC administration of Entyvio, which is currently available in intravenous form. Takeda expects a decision by the end of 2023. The pivotal VISIBLE 1 trial, assessing the SC formulation, involved 216 adult patients and demonstrated a primary endpoint of clinical remission at week 52. The SC formulation aims to offer patients an alternative to IV infusion, enhancing treatment options.

Takeda has received FDA approval for HYQVIA (Immune Globulin Infusion 10% with Recombinant Human Hyaluronidase), enabling treatment of primary immunodeficiency (PI) in children aged 2 to 16. This supplement expands its market presence, as HYQVIA was initially authorized in 2014 for adults. The approval is based on a Phase 3 study demonstrating effective infection protection, showing a mean rate of acute serious bacterial infections (aSBIs) at 0.04 per year, significantly lower than the predefined target. The drug offers a less frequent treatment option (once a month) that can be administered at home after training. Takeda's commitment to plasma-derived therapies is reinforced through this expanded indication, catering to the specific needs of pediatric patients and their families.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced the dosing of the first patient in Takeda’s Phase 3 REDWOOD study for fazirsiran (TAK-999/ARO-AAT), targeting alpha-1 antitrypsin deficiency-associated liver disease (AATD-LD). This event unlocks a $40 million milestone payment from Takeda to Arrowhead. Fazirsiran, an investigational RNA interference therapy, aims to reduce the production of the harmful Z-AAT protein. The study, involving 160 patients, evaluates the drug's efficacy and safety. Fazirsiran has previously received Breakthrough and Orphan Drug Designations from the FDA.

Takeda has announced an investment of $19.5 million in FY2022, granting funds to 21 new U.S. non-profit organizations, bringing its total CSR investment to nearly $40 million. The funds aim to improve equity in health, education, and environment in under-resourced communities. Launched in FY2021, the 'Takeda Cares' program seeks sustainable change by addressing social disparities. The newly funded organizations include food banks, health equity programs, and educational initiatives across major U.S. cities such as Greater Boston, San Diego, and Atlanta. Detailed insights are available in the recently published 'Takeda Cares for Communities Report.'

Takeda announced positive results from the Phase 4 EARNEST study of vedolizumab for chronic pouchitis in the New England Journal of Medicine. The study showed that 31% of participants receiving vedolizumab achieved remission at Week 14, compared to 10% on placebo. This superiority continued with 35% remission at Week 34 versus 18% on placebo. The study confirms vedolizumab's efficacy in treating this condition, with no new safety signals reported. The commitment to alleviating chronic inflammatory gastrointestinal conditions is underscored by Takeda's focus on advancing treatment options for affected patients.