The U.S. FDA staff reviewers have raised concerns regarding the efficacy of Replimune’s drug for a type of skin cancer, as stated in briefing documents released on Tuesday.
Details of the Concerns
The FDA review team concluded that the application does not include an adequate and well-controlled investigation that demonstrates substantial evidence of effectiveness. This comes after 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.
Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.
