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(RTTNews) - Disc Medicine (IRON) announced the submission of a New Drug Application to the FDA for bitopertin for patients aged 12 years and older with erythropoietic protoporphyria, including X-linked protoporphyria. Disc submitted the NDA under the FDA's accelerated approval pathway using reduction of protoporphyrin IX as a surrogate endpoint and requested a Priority Review.

The company said the NDA submission is supported by the results of the Phase 2 BEACON and AURORA studies in EPP, as well as prior data generated by Roche, including a safety database of over 4,000 clinical trial participants.

Disc obtained global rights to bitopertin under a license agreement from Roche in May 2021.

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