Since it was established nearly a year ago by the FDA, the Commissioner\u2019s National Priority Voucher (CNPV) program has been steeped in controversy as a potential tool for government officials to curry favor and reward political allies in the biopharma industry.<\/p>\n
Now, Sanofi has asked that one of its applications be removed from the fast-track program, according<\/a> to a report from Stat.<\/p>\n The French pharma giant has requested that its application for expanded use of its diabetes drug Tzield be dropped from the CNPV track after the director of the FDA\u2019s Center for Drug Evaluation and Research, Tracy Beth H\u00f8eg, M.D., Ph.D., overturned a staff decision to approve the treatment, Stat reports, citing anonymous sources familiar with the discussions between the parties.<\/p>\n An April 21 decision date came and went for the application, with no complete response letter (CRL) issued. While Tzield last month won a separate green light, the potential expansion covered under the CNPV program was not decided on.\u00a0<\/p>\n Tzield was first approved in 2022 to delay the onset of stage 3 Type 1 diabetes in adults and children ages 8 and older whose disease is at stage 2. Then, roughly two weeks ago, the FDA cleared its use for children at least 1 year old.<\/p>\n The CNPV indication, meanwhile, concerns Tzield’s potential use in kids ages 8 and older with stage 3 Type 1 diabetes, the stage at which a clinical diagnosis<\/a> typically occurs, to slow disease progression.<\/p>\n When reached for comment, Sanofi declined to comment directly on its reported request to the FDA, citing confidential discussions with the agency.<\/p>\n \u201cWe\u00a0are\u00a0confident in the\u00a0efficacy and safety\u00a0profile of\u00a0Tzield\u00a0and we\u00a0remain\u00a0committed to working closely\u00a0with the FDA\u00a0throughout this\u00a0review process,\u201d a Sanofi spokesperson wrote in an emailed statement.\u00a0<\/p>\n A representative for the Department of Health and Human Services did not respond to Fierce’s request for comment by publication time.\u00a0<\/p>\n It\u2019s uncertain what impact it would have if the application were to be pulled from the program. Of the first wave of nine drugmakers who got CNPVs, Sanofi was among those who did not apply. The FDA nominated<\/a> the company to receive one because its application addressed an unmet need, Sanofi said upon accepting the nomination in October of last year.\u00a0<\/p>\n The CNPV program aims to shorten the review process for products that align with “national interests” from the 10 to 12 months typically required for a standard review to just 1 to 2 months.<\/p>\n