"We are very pleased that FDA has granted Fast Track designation for EG-1962 for the treatment of SAH," said Brian A. Leuthner, Edge’s Chief Executive Officer.
"The FDA Fast Track designation builds upon the orphan drug designations EG-1962 received from both the FDA and European Commission last year, and provides us with even more momentum to address the significant unmet medical needs in the treatment of aneurysmal subarachnoid hemorrhage (aSAH), also known as a ruptured brain aneurysm. We look forward to working closely with the regulatory authorities to rapidly advance the availability of EG-1962 for patients that suffer this life-threatening and catastrophic event."
Edge expects to begin enrollment in mid-2016 in NEWTON 2, a pivotal Phase 3 multi-center, multi-national, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of EG-1962 versus the standard of care, oral nimodipine, in adults with aSAH. Patients will be enrolled in North America, Europe, Israel and Australasia.
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.
About EG-1962
EG-1962 is a novel polymeric nimodipine microparticle containing nimodipine suspended in a diluent of sodium hyaluronate that utilizes Edge’s proprietary Precisa development platform and that is designed to improve patient outcomes following aSAH.
In addition to Fast Track designation, EG-1962 has been granted orphan drug designation by the FDA and the European Commission.
About aSAH
An aneurysmal subarachnoid hemorrhage, or aSAH, is a brain hemorrhage after which blood from a ruptured aneurysm enters the subarachnoid space, the area between the middle and deepest protective layers of the brain.
Approximately 600,000 individuals worldwide suffer an aSAH annually. In the U.S., approximately 35,000 aSAH patients, with an average age of 52, arrive alive at the hospital each year, and approximately 75 percent of these patients die or suffer permanent brain damage.