Clinuvel Pharmaceuticals Files NEURACTHEL Instant Dossier in Europe
Clinuvel Pharmaceuticals Limited announced the filing of a marketing authorisation dossier for its second pharmaceutical product, NEURACTHEL® Instant (tetracosactide), with national European regulators. This submission is part of the European decentralised procedure (DCP), aiming for commercialization as a prescription pharmaceutical in up to three initial key EU Member States. NEURACTHEL® Instant is a branded generic formulation of tetracosactide, a synthetic peptide analogue of ACTH. The company has identified key European Union Member States for launch based on market factors and existing commercial infrastructure. The global ACTH market is valued at approximately US$1.3 billion annually. Further submissions to other regulatory bodies, including the UK's MHRA and potentially the U.S. FDA, are under evaluation.
Key Highlights
- Clinuvel Pharmaceuticals has filed a dossier for marketing authorisation of NEURACTHEL® Instant with European regulators.
- The filing is part of the European decentralised procedure (DCP) for approval in up to three initial key EU Member States.
- NEURACTHEL® Instant is a branded generic formulation of tetracosactide, a synthetic peptide analogue of ACTH.
- The global ACTH market is estimated at US$1.3 billion annually.
- The DCP review process is intended to take 300 days, excluding potential clock stops.
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