July 28 (Reuters) – The U.S. FDA staff reviewers raised concerns on the efficacy of Replimune’s drug for a type of a skin cancer, ahead of their meeting on July 30, briefing documents showed on Tuesday.
Shares of the company tumbled 22.6% in premarket trading.
“The FDA review team concludes that this BLA (application) does not include an adequate and well-controlled investigation that demonstrates substantial evidence of effectiveness,” the briefing documents said.
The FDA declined to approve the drug for the second time in two years in April, citing reliance on a single-arm study without a control group, and asked for more data from a well-controlled trial demonstrating adequate evidence of the drug’s effectiveness.
(Reporting by Puyaan Singh in Bengaluru; Editing by Anil D’Silva)
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