DBV Technologies has withdrawn the filing for FDA approval of its peanut allergy therapy. The French biotech pulled the BLA after talks with the agency revealed gaps in the manufacturing and quality-control sections of the filing.
Doubts about DBV’s ability to get its peanut allergy treatment, Viaskin Peanut, past the FDA emerged last year when a phase 3 trial of the candidate failed to clear the efficacy bar set by the agency. However, with Viaskin Peanut statistically outperforming placebo and generating positive results against other endpoints, DBV felt the overall data package supported approval.
Now, DBV has learned the FDA thinks aspects of the data package are deficient, although not the sections investors may have been worried about after seeing the phase 3 results. While DBV said the FDA didn’t raise concerns about the clinical module, the agency did find fault with the sections on manufacturing procedures and quality control, specifically the lack of detail regarding data.
DBV thinks it can resolve the problem without running additional clinical studies and is now working to get the filing back in front of the FDA.
“We remain confident in the clinical profile of Viaskin Peanut and its potential to offer treatment to peanut-allergic children. Our plan is to address these concerns as quickly as possible and to work closely with the FDA to provide an updated and complete file,” DBV CEO Daniel Tassé said in a statement.
DBV is yet to provide a target data for the resubmission, but the delay looks set to hand the advantage to Aimmune Therapeutics, its rival for the peanut allergy market. DBV filed its BLA in October. Aimmune is due to submit its application this month. Both candidates have breakthrough status, meaning that, barring further twists, Aimmune could now get its drug to market first.
Shares in Aimmune rose 6% following the news. DBV’s stock fell by more than 50%.