The epicutaneous immunotherapy patch BLA was previously submitted to the FDA last year, but withdrawn due to concerns over manufacturing procedure and quality control.
The Biologics License Application (BLA) for potential skin patch peanut allergy treatment Viaskin Peanut has been submitted to the US Food and Drug Administration (FDA).
Biopharmaceutical company DBV Technologies will receive a marketing decision on their novel pediatric epicutaneous immunotherapy (EPIT) in the near future—approximately 8 months after the company withdrew an application following an FDA request for additional manufacturing procedure and quality control data.
The newest BLA submission includes additional data to address the FDA’s request in 2018, while retaining its application for the treatment of children aged 4-11 years old with peanut allergies. The application features data from an eight-study clinical program, including a pair of phase 3 trials (PEPITES and REALISE) which assessed the EPIT patch in pediatric peanut-allergic patients versus placebo over 12 months and 6 months, respectively.
In PEPITES clinical data presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2019 Annual Meeting this February, investigators reported the 238 pediatric patients administered 250 mcg Viaskin over 12 months reported a 35.3% responder rate, versus the 13.6% reported in the 118 patients administered placebo.
The newly submitted application comes 3 months following the announcement that investigative peanut immunotherapy AR101 from Aimmune Therapeutics will receive an FDA advisory committee vote for a similar pediatric patient indication in September of this year. The FDA will rule on AR101 by January 2020.
Within 4 months, the US drug market could have multiple therapy options for peanut allergy desensitization—a market which was previously vacant, and without many clinical possibilities. In an interview with MD Magazine® at AAAAI 2019, Edwin Kim, MD, MS, and Scott Commins, MD, PhD, colleagues from the 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.”
Daniel Tasse, chief executive officer of DBV, called the newly submitted application an “important milestone” for the company.
“Everyone at DBV is highly committed to potentially addressing the significant unmet medical need facing peanut-allergic patients,” Tasse said in a statement. “We would also like to thank our investigators, clinical trial sites, as well as the children living with peanut allergy and their families for all of their help in the development of Viaskin Peanut.”