May 5 (Reuters) – U.S. Food and Drug Administration Commissioner Dr. Marty Makary on Tuesday defended the agency’s decision to not approve Replimune’s drug for advanced skin cancer.
“If you read our, what we call our complete response letter, you will see the details of the FDA logic,” Makary said in an interview on CNBC.
Replimune shares were down 10% in morning trading.
Last month, the FDA declined to approve Replimune’s drug, citing insufficient data from studies. It said the company relied on a single‑arm study for the medicine without a control group.
In its rejection letter, the agency said the company must provide data from a well-controlled trial, demonstrating adequate evidence of effectiveness.
“The FDA clearly recommended that control group. The company clearly did not do that control group. And so, by law, we can only approve drugs with substantial evidence,” Makary said in the CNBC interview.
“A very simple, clear message to the world, if your drug works, it’s going to get approved,” he added.
Replimune did not immediately respond to a Reuters request for comment.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shinjini Ganguli)
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