May 6 (Reuters) – Sanofi has asked the U.S. Food and Drug Administration to pull its diabetes drug out of the regulator’s new fast-track review program, STAT News reported on Wednesday.
The move comes after the director of the FDA’s Center for Drug Evaluation and Research, Tracy Beth Høeg, disagreed with a staff decision to approve the drug, teplizumab, the report said, citing sources familiar with the dispute.
Teplizumab, branded as Tzield, was being reviewed to delay the progression of stage 3 type 1 diabetes in patients eight years of age and older. It was approved in the U.S. last month to delay the onset of stage 3 T1D in patients as young as one year and older.
“We will not comment on our confidential ongoing discussions with the FDA regarding our supplemental biologics application… which is currently pending a decision,” a Sanofi spokesperson said.
According to the STAT report, Høeg is concerned that the drug’s benefits do not outweigh its risks. She is worried about the risk of developing Epstein-Barr virus and cancer in particular.
Sanofi said it has observed three cancer cases out of more than 1,000 patients treated with teplizumab over 30 years. But no causal relationship was established between the cancers and teplizumab, it said, adding that no cases were reported in post-marketing surveillance.
Reuters reported in January that the FDA stalled its review of Tzield over adverse events, including two related to seizure and blood clotting and one death.
Launched last year, the FDA commissioner’s national priority voucher program promised decisions in one or two months, compared to the typical timeline of 10-12 months, on a limited number of drugs deemed critical to public health or national security.
The Department of Health and Human Services did not immediately respond to a Reuters request for comment.
(Reporting by Sneha S K and Mariam Sunny in Bengaluru; Editing by Shilpi Majumdar)
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