Omeros Gets Faster FDA Review of Huntington's Drug
NEW YORK (AP) — Drug developer Omeros said Wednesday that regulators will conduct a faster review of its drug OMS824, a treatment for cognitive impairment in patients with Huntington's disease.
The Seattle company said the Food and Drug Administration granted fast track status for OMS824. The designation is intended to speed up the review of drugs that treat serious medical conditions and fill an unmet medical need. Huntington's disease causes muscle problems and later causes mental deterioration.
Omeros says OMS824 blocks an enzyme that is linked to diseases that affect cognition, including Huntington's and schizophrenia. The company has conducted early safety trials of the drug, and this quarter it plans to start enrolling patients in a mid-stage trial that will measure its effectiveness.
Shares of Omeros rose 53 cents, or 4.7 percent, to $11.78 in morning trading Wednesday. Its shares have doubled in the past year.
In October Omeros said OMS824 was designated an orphan drug as a treatment for Huntington's disease. Orphan drug status is awarded to medications that are designed to treat diseases that affect fewer than 200,000 people in the U.S. and represent a major improvement in treatment. The status comes with regulatory incentives, reduced fees, a faster review by the FDA, and it means competing drugs could be blocked from the market for up to seven years.
Omeros Corp. doesn't have any approved products. Its most advanced experimental drug is OMS302, which is designed to reduce pupil constriction during lens replacement surgery and ease pain after the procedure. It hopes to launch OMS302 in 2014. The company is also studying OMS103HP, a drug intended to reduce early pain after arthroscopic surgery, and OMS201, an anti-inflammatory drug and muscle relaxant intended for use during urology procedures.