Posted on Jan 01, 2019, 2 a.m.
This will be bad new to those with peanut allergies as DBV Technologies has withdrawn their filing for FDA approval on its peanut allergy therapy after talks with the agency revealed gaps in manufacturing and quality control sections of the filing.
Last year during a phase 3 trial of Viaskin Peanut doubts began to emerge when the candidate failed to clear the efficacy bar set by the FDA; however it outperformed placebo and generated positive results against other endpoints leading DVB think the overall data package supported approval.
The FDA found aspects of the data package to be deficient, although not in the sections investors may have been concerned about with the phase 3 results; concerns were not raised about the clinical module, rather with the sections on manufacturing procedures and quality control; specifically lack of detail regarding data.
DBV remains confident in the clinical profile of the candidate and the potential to offer treatment to peanut allergic children, believing the problems can be resolved without running additional clinical studies and are now working on getting the filing back in front of the FDA.
Target data for resubmission has not been provided by DBV, but the delay opens a window of opportunity for Aimmune Therapeutics their rival in the peanut allergy market. Both company candidates have breakthrough status, barring any further twists Aimmune may now be able to get its candidate to the market first; the race of the nutcrackers is on.
Materials provided by:
Note: Content may be edited for style and length.