'Sanofi asks to pull Tzield bid from FDA's controversial CNPV program'

 Since it was established nearly a year ago by the FDA, the Commissioner’s 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.

Now Sanofi has asked that one of its applications be taken out of the fast-track program, according to a report from Stat.

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’s Center for Drug Evaluation and Research, Tracy Beth Høeg, M.D., Ph.D., overturned a staff decision to approve the treatment, Stat reports, citing anonymous sources familiar with the discussions between the parties.

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. 

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 are at stage 2. Then, roughly two weeks ago, the FDA cleared its use in children who were at least age 1.

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 typically occurs, to slow disease progression.

When reached for comment, Sanofi declined to comment directly on its reported request to the FDA, citing confidential discussions with the agency.

“We are confident in the efficacy and safety profile of Tzield and we remain committed to working closely with the FDA throughout this review process,” a Sanofi spokesperson wrote in an emailed statement. 

A representative for the Department of Health and Human Services did not respond to Fierce's request for comment by publication time. 

It’s 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 the company to receive one because its application addressed an unmet need, Sanofi said upon accepting the nomination in October of last year. 

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 to 1 to 2 months.

In January, the FDA delayed its review of Tzield because of reports of two seizures and one death from blood clotting, according to Reuters. Since then, FDA staffers decided that the risks of treatment could be managed by labeling, Stat reported this week.

“Based on all available information, no causal relationship has been established between Tzield and the single case with a reported fatal outcome,” according to the Sanofi spokesperson. 

The spokesperson continued, “Over 1,000 patients have been treated with teplizumab over the course of 30 years of clinical development. Three cases of malignancies have been observed in these programs. In each of these cases, no causal relationship was established between the malignancies and teplizumab.”

https://www.fiercepharma.com/pharma/sanofi-requests-exit-controversial-cnpv-fast-track-program-stat