GemVax announced on the 29th that its progressive supranuclear palsy (PSP) treatment drug 'GV1001' has been designated as an orphan medicinal product (OMP) by the European Medicines Agency (EMA). Earlier this month, it received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA).
GV1001 has been designated as an orphan medicinal product by major new drug development regulatory agencies in the United States, Europe, and Korea, allowing it to benefit from all applicable development advantages. PSP is an atypical parkinsonian syndrome that causes balance impairment, eye movement disorders, and deficits in speech and cognitive function, progressing much faster than Parkinson's disease despite similarities in symptoms.
The EMA provides benefits such as scientific advice, development support, fee reductions or exemptions for regulatory submissions, and 10 years of market exclusivity for treatments developed for rare diseases affecting fewer than 50,000 patients in Europe.
GemVax previously secured advantages from the FDA orphan drug designation, including seven years of market exclusivity in the United States and a maximum 25% tax deduction on clinical expenses. The company expects that obtaining the FDA's fast track designation on the 7th will further accelerate the clinical development and approval process for PSP treatments. It plans to intensify efforts to promote global Phase 3 clinical trials.
A representative from GemVax noted, "Receiving orphan medicinal product designations from both the United States and Europe, the most influential drug markets in the world, acknowledges both the developmental potential and necessity of the treatment. We will do our utmost to quickly advance global clinical trials that utilize various benefits to provide new treatment options for PSP patients."