Viaskin Peanut data sufficient for BLA

DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) said FDA has agreed that the available safety and efficacy data for peanut allergy candidate Viaskin Peanut (DBV-712) will support a BLA submission for the product. DBV plans to submit the BLA in 2H18.

In October, Viaskin Peanut missed its primary endpoint in the Phase III PEPITES trial to treat peanut allergy in patients ages 4-11. In the trial, Viaskin Peanut given for 12 months significantly improved response rate vs. placebo (35.3% vs. 13.6%, p=0.00001), but the lower bound of the 95% CI for the response rate difference (12.4%, 29.8%) did not reach the 15% threshold required to meet the primary endpoint under the trial’s proposed statistical analysis plan submitted to FDA...