Omeros Corp. files for orphan drug status for OMS721 in Immunoglobin A Nephropathy

Release Date: 12-Dec-2016

Omeros Corp. has filed application for orphan drug designation to U.S Food and Drug Administration and European Commission for OMS721 in Immunoglobin A Nephropathy. The agency is planning to initiate OMS721 phase 3 programs in both IGA nephropathy and HSCT-TMA next year.

The FDA and EMA’s designation of orphan status is granted to encourage new developments and therapies for rare diseases and disorders. Orphan Status can be applied to products proven safe and effective in treating conditions that affect a relatively small number of patients, and the designation may entitle up to seven years of US marketing exclusivity upon regulatory approval. Companies whose drugs have an orphan designation also receive certain tax credits and are exempted from paying prescription drug user fees normally required of companies submitting products for approval.

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