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.
For Orphan Drug Clinical Insight Reports Contact: firstname.lastname@example.org
Need custom market research solution? We can help you with that too.
Kuick Research is a market research and analytics company that provides targeted information for critical decisions at business, product and
service levels. We are quick, predictive and known by the recommendations we have made in the past. Our result-oriented research methodology offers
understanding of multiple issues in a short period of time and gives us the capability to keep you full with loads of practical ideas.