Madrigal receives FDA accelerated approval for Rezdiffra, first NASH therapy

MADRIGAL PHARMACEUTICALS, INC.

FDA grants accelerated approval for Rezdiffra in NASH with F2-F3 fibrosis; first approved therapy for NASH.
Approval based on Phase 3 MAESTRO-NASH: improved fibrosis and NASH resolution at 52 weeks vs placebo.
Prescribing info does not require liver biopsy; weight-based dosing (80mg <100kg, 100mg >=100kg).
Rezdiffra expected available in US in April via specialty pharmacy; patient support programs.
Most common adverse reactions: diarrhea, nausea, pruritus, abdominal pain. Continued approval contingent on confirmatory outcomes data.

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