DBV tries again with peanut allergy BLA

French biotech DBV Technologies (Euronext: DBV) has returned to the US Food and Drug Administration (FDA) with a new Biologics License Application (BLA) for Viaskin Peanut.

The company claims that this revised application addresses the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December 2018, when DBV voluntarily withdrew its prior BLA submission.

Viaskin Peanut is being developed for the treatment of peanut-allergic in children aged four to 11 years and is DBV’s lead product candidate based on epicutaneous immunotherapy.