Trethera Announces FDA Orphan Drug Designation Granted to TRE-515 in the Treatment of Acute Disseminated Encephalomyelitis
LOS ANGELES, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Trethera Corporation (Trethera), a biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Status (ODS) to TRE-515, Tretheras first-in-class drug for the treatment of acute disseminated encephalomyelitis (ADEM).
- LOS ANGELES, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Trethera Corporation (Trethera), a biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Status (ODS) to TRE-515, Tretheras first-in-class drug for the treatment of acute disseminated encephalomyelitis (ADEM).
- No medications have been specifically approved by the FDA to treat it, said Dr. Peter Clark, a specialist member of the Trethera Scientific Advisory Board.
- The ODS designation qualifies Trethera for certain incentives, which include FDA assistance in designing clinical trials, access to the FDA Orphan Drug Grants Program, exemption from the drug approval application fee and eligibility for seven years of marketing exclusivity.
- Trethera's innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally taken capsule twice designated by the FDA as an Orphan Drug.