FDA granted Fast Track designation to SGX301 (synthetic hypericin) for the first-line treatment of cutaneous T-cell lymphoma.
The designation is designed to facilitate the development and expedite the review of new drugs. Soligenix Inc., the drug’s sponsor, will be eligible to submit a new drug application for SGX301 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months. SGX301 has already received orphan drug designation from the FDA.
SGX301 is a first-in-class photodynamic therapy utilizing visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer which is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. In a phase II study in CTCL, patients experienced a statistically significant (p < 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective: 58.3 percent compared to 8.3 percent, respectively.
