Takeda : FDA Grants Priority Review Of TAK-755 For Treatment Of Clotting Disorder

(RTTNews) - Takeda (TAK) said that the U.S. Food and Drug Administration has accepted Takeda's Biologics License Application for TAK-755, an enzyme replacement therapy for the treatment of congenital thrombotic thrombocytopenic purpura or cTTP, an ADAMTS13 deficiency disorder.

The FDA has Granted TAK-755 Priority Review and Rare Pediatric Disease Designation. TAK-755 has previously received Fast Track Designation and Orphan Drug Designation in cTTP.

If approved, TAK-755 would be the first and only recombinant ADAMTS13 (rADAMTS13) replacement therapy for cTTP, the company said in a statement.

cTTP is an ultra-rare inherited form of thrombotic thrombocytopenic purpura (TTP), a chronic and debilitating clotting disorder caused by a deficiency in ADAMTS13 protease. Acute TTP has a mortality rate of more than 90%, if left untreated.

Takeda is also investigating the safety, efficacy and pharmacokinetics of TAK-755 treatment in immune-mediated TTP (iTTP) in an ongoing Phase 2b study.

BLA acceptance by the U.S. FDA has no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024.

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