The United States Food and Drug Administration has accepted a BLA for Viaskin Peanut from DBV Technologies for the treatment of peanut-allergic children ages 4 to 11, which previously withdrew a BLA in 2018 after request from the FDA requested additional data on its manufacturing procedures and quality controls.
The United States Food and Drug Administration(FDA) has accepted the Biologics License Application(BLA) submitted by the biopharmaceutical company DBV Technologies for their skin path peanut allergy treatment Viaskin Peanut for the treatment of peanut-allergic children ages 4 to 11.
The BLA for the non-invasive, once-daily epicutaneous patch, which is supported by data from 8 clinical trials including the PEPITES and REALISE phase 3 trials, received a target action date from the FDA of August 5, 2020.
“We commend the tireless efforts of the DBV team, the investigators and the more than 1,000 patients living with peanut allergies who participated in our clinical trials and made this milestone possible,” said Daniel Tassé, chief executive officer of DBV Technologies. “We know children and their families are seeking a safe and effective treatment that may fit into their daily lives.”
Of the 8 clinical trials examining the use of Viaskin Peanut, 4 were phase 2 clinical trials and 2 were phase 3 trials. The PEPITES trial involved 238 pediatric patients administered 250 mcg Viaskin over 12 months and investigators observed a 35.3% responder rate with the treatment versus 13.6% in the placebo group.
The BLA for Viaskin Peanut was submitted on August 6, 2019 and comes after the company withdrew a previous BLA in December 2018. DBV Technologies pulled the aforementioned BLA when the FDA requested additional data on its manufacturing procedures and quality controls.
Additionally, Viaskin Peanut received Breakthrough and Fast Track Designation from the FDA in 2015 and 2012, respectively.
In an interview with MD Magazine® at AAAAI 2019, Edwin Kim, MD, MS, of University of North Carolina School of Medicine, elaborated on what a suddenly viable market could mean for treating food allergy.
“I will say, sort of from the clinical allergist point of view—coming back to this theme of patient choice, it is going to be very important,” Kim said. “It would be really nice to have multiple options, because it probably is not a one-size-fits-all when it comes to peanut-allergic patients.”
DBV Technologies noted in a release that Viaskin Peanut had not been approved for marketing by the FDA or any other health authority and the safety and efficacy had been evaluated by the FDA or any other health authority.