Mirum hepatitis D drug succeeds in second pivotal trial

· Health · United States

Mirum Pharmaceuticals’ hepatitis D treatment succeeded in the second of two pivotal trials. The Phase 3 AZURE-4 study enrolled 113 treatment-naïve patients, Endpoints News reported. Mirum now plans an FDA submission for the treatment. The result comes as competition is brewing in a growing hepatitis D market. A second pivotal success is a key step toward approval; the immediate effect is that Mirum can prepare a regulatory filing while facing rivals in the same space.

Why it matters：A second pivotal win puts Mirum closer to an FDA filing in a competitive hepatitis D market and raises pressure on rival late-stage programs.

Key points

  • The trial was called AZURE-4 and enrolled 113 treatment-naïve patients.
  • It was the second of two pivotal trials for Mirum’s hepatitis D treatment.
  • Mirum plans an FDA submission as competition grows.

Sources (original reporting)

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