Posted by Michael Wonder on 14 Feb 2019
DBV Technologies provides update on regulatory status of Viaskin Peanut for the treatment of peanut-allergic children 4 to 11 years of age
13 February 2019 - Progress made to date to enable resubmission in Q3 2019.
DBV Technologies today announced that its planned resubmission of the biologics license application (BLA) to the U.S. FDA for Viaskin Peanut in the treatment of peanut-allergic children 4 to 11 years of age is anticipated in the third quarter of 2019.
In December 2018, DBV voluntarily withdrew its BLA for Viaskin Peanut following correspondence with the FDA regarding additional data needs on manufacturing procedures and quality controls. Based on the progress in addressing the FDA’s guidance, the Company anticipates compiling the required information for the resubmission of its Viaskin Peanut BLA in the third quarter of 2019.
