FDA Agrees on Proposal for Initial Pediatric Study Plan for SGX301

The FDA has agreed on a proposal for an initial pediatric study plan (iPSP) for SGX301 for the treatment of cutaneous T-cell lymphoma (CTCL).

The agreed iPSP stipulates the intention to request a full waiver of pediatric studies upon submission of a new drug application (NDA). The iPSP is one of the regulatory requirements that must be met prior to submitting the NDA.

The FDA decision is in line with moves by the EMA and the Medicines and Healthcare Products Regulatory Agency in the UK. Both agencies have previously granted product-specific waivers for the requirement of pediatric studies in applications for marketing authorization.

SGX301 is a novel, first-in-class, photodynamic therapy utilizing visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by malignant T-cells, and then activated by visible light 16 to 24 hours later.

The therapy was evaluated in the phase III FLASH trial, and overall, was found to be well tolerated despite extended and increased use of the product to treat multiple lesions.

Source: PR Newswire via Soligenix, July 2022