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ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV) announced today that the U.S. Food and Drug Administration (FDA) has agreed to allow the company 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).
On January 8, 2018, the ContraVir Executive Team met with the FDA’s Division of Antiviral Products at the Center for Drug Evaluation and Research, to review and discuss the data generated for TXL™ to date, as well as the data package that would be required for the filing of an NDA and successful registration of TXL ™ in the US leveraging the 505(b)2 Regulatory Pathway. On February 7, 2018, ContraVir received final written minutes from the FDA summarizing the outcome of the meeting and feedback received.
Key highlights from the meeting outcome include:
- Agreement on an abbreviated non-clinical Development Program
- Agreement on a Clinical Pharmacology Package
- Agreement on the major elements of Phase 3 trial design in treatment-naïve patients with chronic hepatitis B (both HBeAg and HeAg), including duration of treatment, clinical endpoints, comparator and;
- Agreement on number of patients for the safety database needed for NDA submission
The outcome of the meeting with FDA is a positive step towards the further execution of the streamlined development and registration of TXL™ in the US, which is expected to allow a faster and more cost-effective path to approval and commercialization in the US.
“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.”
“The outcome of the meeting with FDA allows TXL™ to leverage the 505(b)2 Regulatory Pathway as one of the lead compounds in development for HBV,” stated Carol L.Brosgart, MD, Clinical Professor of Medicine, Epidemiology and Biostatistics, University of California, San Francisco, an infectious diseases, hepatology, and biotechnology expert, and the Chair of ContraVir’s Scientific Advisory Board. “TXL™’s liver-targeting design advances the development of the compound as a direct acting antiviral, which we anticipate to be the backbone to potential functional curative regimens.”
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发表于 2018-2-13 09:40
