Remedy Pharmaceuticals, a privately-held pharmaceutical company focused on bringing life-saving hospital-based treatment to people affected by central nervous system (CNS) related edema, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug, CIRARA, for the treatment of Large Hemispheric Infarctions (LHI).
The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. FDA may consider a "rolling review" of completed sections of the New Drug Application (NDA) before the complete application is submitted. Fast Track designation drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
“We are very pleased to achieve this additional important milestone for our LHI program, following the FDA’s recent acceptance of our investigational new drug (IND) application,” said Sven Jacobson, CEO of Remedy Pharmaceuticals. “This latest development provides further momentum as we advance CIRARA, with the near-term goal to initiate our phase 3 clinical trial by the end of this year.”
CHARM (Cirara in large Hemispheric infarction Analyzing modified Rankin & Mortality) is a phase 3 trial in patients with large hemispheric infarction (LHI). LHI is a devastating disease associated with significant disability and mortality. Brain swelling (often termed “malignant edema”) frequently occurs following LHI as a result of the opening of Sur1-Trpm4 channels in the capillary endothelium, which leads to dysfunction of the blood brain barrier. Such swelling can compromise arterial inflow to surrounding tissues, causing further ischemic damage and enlargement of the infarct, and frequently results in brain herniation and death.
