February 24, 2024

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First-In-Class Photodynamic Therapy Rejected by FDA

First-In-Class Photodynamic Therapy Rejected by FDA



 

First-In-Class Photodynamic Therapy Rejected by FDA.

On February 14 , Soligenix announced that it had received a New Drug Application ( NDA ) from the U.S. Food and Drug Administration ( FDA ) for its synthetic hypericin photodynamic therapy HyBryte (synthetic hypericin) for the treatment of early-stage cutaneous T -cell lymphoma ( CTCL ) Refusal to Submit ( RTF ) Letter.

 

First-In-Class Photodynamic Therapy Rejected by FDA.

On February 14 , Soligenix announced that it had received a New Drug Application ( NDA ) from the U.S. Food and Drug Administration ( FDA ) for its synthetic hypericin photodynamic therapy HyBryte (synthetic hypericin) for the treatment of early-stage cutaneous T -cell lymphoma ( CTCL ) Refusal to Submit ( RTF ) Letter.

 

Following an initial review, the FDA determined that the company’s NDA submission on December 14 , 2022 was not complete enough for substantive review. Affected by this news, Soligenix shares fell 18.10% on the day .

 

This NDA is based on Phase II data. Data from the study showed a statistically significant improvement in CTCL patients treated with HyBryte compared to no improvement with placebo .

 

CTCL is a rare cancer that affects more than 25,000 patients in the United States and represents an unmet medical need. At the time of HyBryte’s NDA submission , the company predicted approval in the second half of 2023 and estimated the potential global market for HyBryte in CTCL to be over $ 250 million.

 

According to a Soligenix press release, the plan calls for a Type A meeting with the FDA to clarify and respond to the issues identified in the letter and to seek additional guidance on the information the agency is requesting to resubmit the NDA to be deemed acceptable.

 

HyBryte is a new, first-in-class photodynamic therapy activated by safe visible light .

The active ingredient in HyBryte is the potent photosensitizer synthetic hypericin, and the ointment formulation is applied topically to skin lesions, taken up by malignant T cells, and then activated by visible light approximately 24 hours later.

 

According to Soligenix , using light in the red – yellow spectrum can penetrate deeper into the skin and treat more severe skin conditions than commonly used ultraviolet light .

HyBryte avoids the risk of secondary malignancies, including melanoma, inherent with frequently used DNA- damaging drugs and other phototherapies that rely on UV exposure.

 

HyBryte has received Orphan Drug and Fast Track Designations from the FDA , as well as Orphan Drug Designation from the European Medicines Agency ( EMA ).

 

 

First-In-Class Photodynamic Therapy Rejected by FDA

(source:internet, reference only)


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