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# Disc Medicine Plans NDA Refiling After Favorable Trial Data
- URL: https://www.fdaweb.com/disc-medicine-plans-nda-refiling-after-favorable-trial-data/
- Published: 2026-10-19T21:44:13.000Z
- Updated: 2026-10-19T21:44:13.000Z
- Author: David McFarland
- Tags: Drugs

Disc Medicine says it will resubmit an NDA by year-end for bitopertin in adults and adolescents with erythropoietic protoporphyria (EPP) following just-reported APOLLO Phase 3 favorable data. According to the company, the results demonstrated statistically significant and clinically meaningful benefits across all study endpoints.

Earlier this year, FDA issued Disc a [complete response letter](https://download.open.fda.gov/crl/CRL%5FNDA220707%5F20260213.pdf?ref=fdaweb.com) (CRL) for its NDA seeking accelerated approval under the Commissioner’s National Priority Voucher pilot program. The letter said FDA had concluded that while mid-stage trial data showed the drug significantly reduced a key biomarker associated with the rare blood disorder, the application did not adequately demonstrate that biomarker changes were reasonably likely to predict clinical benefit, according to the company.

In June, Disc said it had [reached agreement](https://www.fdaweb.com/disc-medicine-says-fda-open-to-bitopertin-approval-path/) with the agency on a potential regulatory path forward for bitopertin. The agency indicated that a successful Phase 3 (APOLLO) trial could support a response to the drug's recent CRL and potentially lead to traditional approval for treating the rare genetic disorder characterized by severe, painful reactions to sunlight.