Novo Nordisk gets FDA fast track status for ATTR heart disease drug

The U.S. Food and Drug Administration granted Fast Track Designation to coramitug, an investigational antibody for treating ATTR amyloidosis with cardiomyopathy, Prothena Corporation (NASDAQ: PRTA) announced.

Novo Nordisk holds worldwide rights to coramitug and is evaluating the drug in the Phase 3 CLEOPATTRA clinical trial involving approximately 1,280 participants with ATTR-CM. The study's primary completion is expected in 2029.

ATTR-CM is a progressive disease caused by transthyretin protein deposits in the heart muscle. Current therapies may slow disease progression but do not clear existing deposits. Coramitug is designed to promote clearance of transthyretin amyloid through antibody-mediated phagocytosis.

Fast Track Designation is intended to facilitate development and expedite review of investigational drugs that treat serious conditions and address unmet medical needs.

"We are encouraged by Novo Nordisk's receipt of Fast Track Designation for coramitug, which underscores their continued commitment to advancing coramitug for patients living with ATTR-CM," said Gene Kinney, President and Chief Executive Officer of Prothena.

Novo Nordisk acquired full worldwide rights to the ATTR amyloidosis business and pipeline from Prothena in July 2021. Under the acquisition agreement, Prothena is eligible to receive up to $1.2 billion including an upfront payment and clinical development and sales milestones, with $150 million earned to date.

In a Phase 2 clinical trial, coramitug 60 mg/kg significantly reduced NT-proBNP levels from baseline in patients with ATTR-CM, with more than 80% already receiving standard care treatment.

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