LEO Pharma A/S is not saying for certain that it has closed the door on its ointment formulation of isotretinoin, but said on 21 August the failure of TMB-001 to hit the primary endpoint in a Phase III study in congenital ichthyosis means it will not file a new drug application seeking the first approved therapy in the orphan dermatologic disease.
Key Takeaways
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Leo’s topical isotretinoin formulation for congenital ichthyosis missed its primary endpoint in a Phase III study and will not be filed for US approval.
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Acquired in the Timber Pharmaceuticals buyout last year, TMB-001 was the most advanced candidate for congenital ichthyosis, which has no approved drugs
Brian Hilberdink, North America EVP for the Denmark-based dermatology firm, told Scrip that no final decision has been made on the candidate’s future and that Leo could consider developing TMB-001 for other indications
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