1:44 PM
 | 
Feb 14, 2018
 |  BC Extra  |  Company News

Viaskin Peanut data sufficient for BLA

DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) said Wednesday that 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.

The news sent DBV shares up €9.04 (27%) to €41.94 on Euronext and $5.37 (26%) to $26.23 on NASDAQ.

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 (see BioCentury Extra, Oct. 20, 2017).

In November, DBV said Viaskin Peanut met the primary safety endpoint in the Phase III REALISE trial in the indication.

Viaskin Peanut is a patch that delivers peanut proteins epicutaneously.

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Extra

Article Purchase

Purchase this article for limited one-time distribution and website posting

$750 USD