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ContraVir Pharmaceuticals Receives Regulatory Shortcut

To streamline the development and registration of TXL for the treatment of Chronic Hepatitis B

By: Betsy Louda

, Contract Pharma

ContraVir Pharmaceuticals announced today that the U.S. Food and Drug Administration has agreed to allow them to utilize the 505(b)(2) Regulatory Pathway to streamline the development and registration of TXL for the treatment of Chronic Hepatitis B.

 

The 505(b)(2) Regulatory Pathway allows a company to rely upon FDA’s previous findings of safety and efficacy of an approved and marketed product to supplement its own safety and efficacy data, and may be considered in the review by the FDA of a future New Drug Application (NDA).

 

“We are very grateful the FDA supports our pursuit of the 505(b)(2) Regulatory Pathway,” said James Sapirstein, chief executive officer of ContraVir. “This critical feedback will allow us to significantly shorten our non-clinical development program by at least 12-18 months, and will accelerate our clinical program towards registration.”

 

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