The US Food and Drug Administration (FDA) has granted fast-track designation to Opexa Therapeutics’ Tovaxin drug candidate, used to treat secondary progressive multiple sclerosis.
The fast-track status will facilitate to develop and expedite the review of drugs intended to treat serious or life-threatening conditions.
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Fast-track priority review products are expected to be approved during the first review cycle, resulting in a halved review period compared to those without the designation.
Opexa president and CEO Neil Warma said the receipt of fast-track designation will advance Tovaxin through the clinical and regulatory process.
