Huntington's Disease Society of America
Omeros’ Huntington's Disease Drug Granted Fast-Track Status at the FDA
Press release from Omeros website.
Fast track designation at the Food and Drug Administration (FDA) is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need, such as Huntington’s disease. Fast Track designation was requested by Omeros for their drug, OMS824. OMS824 is a phosphodiesterase 10 (PDE10) inhibitor currently in clinical trials for schizophrenia, however it is believed that it may prove useful in alleviating some of the symptoms associated with HD.
The purpose of the Fast Track program is to get important new drugs to the patient as quickly as possible. The goal of the FDA is to review drugs awarded Fast Track status within 60 days of submission of the New Drug Application (NDA).
Besides an accelerated review process for OMS824, the designation from the FDA means that OMS824 is eligible for some or all of the following:
- More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
- More frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers
- Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
- Rolling Review, which means that a drug company can submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
More information on the upcoming clinical trial for OMS824 in HD patients will be posted on the HDSA website when made available.