Since its creation by the FDA nearly a year ago, the Commissioner’s National Preference Voucher (CNPV) program has been embroiled in controversy as a potential tool for government officials to favor and reward political allies in the biopharmaceutical industry.
Sanofi is currently requesting that one of its applications be removed from the fast track program, according to a report from the statistics office.
The French pharmaceutical giant has asked the company to remove its diabetes drug Twyld’s expanded use application from the CNPV track after Tracy Beth Hogue, M.D., director of the FDA’s Center for Drug Evaluation and Research, reversed her staff’s decision to approve the treatment, Stat reported, citing anonymous sources familiar with discussions between the parties.
The decision date for the application was April 21, but no complete response letter (CRL) was issued. Zierud received a separate green light last month, but no decisions had been made on potential expansions under the CNPV program.
Tzield was first approved in 2022 to delay the onset of stage 3 type 1 diabetes in adults and children aged 8 years and older who have stage 2 diabetes. And about two weeks ago, the FDA cleared it for use in children at least 1 year old.
Meanwhile, the CNPV indication raises concerns that Zierud could be used to slow the progression of the disease in children aged 8 years and older with stage 3 type 1 diabetes, the stage at which clinical diagnosis is usually made.
When asked for comment, Sanofi declined to comment directly on the reported request to the FDA, citing confidential discussions with the agency.
“We are confident in the efficacy and safety profile of TZIELD and remain committed to working closely with the FDA throughout this review process,” a Sanofi spokesperson said in an emailed statement.
Representatives from the Department of Health and Human Services did not respond to Fierce’s request for comment by the time of publication.
It is unclear what the impact will be if the application is removed from the program. Of the nine pharmaceutical companies in the first wave that received CNPV, Sanofi was one of those that did not apply. When Sanofi accepted the nomination last October, it said the FDA nominated it because its application addresses an unmet need.
The CNPV program aims to shorten the review process for products in the “national interest” from the typical 10-12 months for standard reviews to just one to two months.
According to Reuters, the FDA delayed its review of Zield in January after reports of two seizures and one death from a blood clot. FDA officials have since determined that the risks of the treatment can be managed through labeling, Statistics reported this week.
A Sanofi spokesperson said: “Based on all available information, no causal link has been established between Zield and a single case in which a fatal outcome was reported.”
The spokesperson continued: “Over the course of 30 years of clinical development, more than 1,000 patients have been treated with teplizumab. Three cases of malignancy were observed in these programs. In each of these cases, no causal relationship was established between the malignancy and teplizumab.”
