DBV's peanut prevention patch approaches key stage of approval process
Almost a year and a half after DBV Technologies pulled its peanut allergy immunotherapy patch from FDA review, the biotech will get their day in court. The FDA has scheduled an advisory committee hearing for May 15.
In the two-horse race to develop the first immunotherapy for peanut allergy, DBV had the early lead, filing an NDA for their patch in 2018. But on December 20 of that year, the company withdrew their application after, they said, meeting with regulators and determining they had not submitted “sufficient detail regarding data on manufacturing procedures and quality controls.” Aimmune filed their BLA 3 days later and won approval as the first immunotherapy for peanuts this month.
Although they cited manufacturing and quality controls for their withdrawal, there have long been concerns about the effectiveness of DBV’s patch, especially in comparison to Aimmune’s capsule. The company’s 2017 Phase III trial was a failure; although 35% of patients responded to the patch, it wasn’t a statistically significant improvement over the placebo arm. The company blamed an unusually high placebo response and claimed the FDA encouraged them to file anyway.
Patients who took Aimmune’s capsule in their Phase III trial had a 67% chance of avoiding a severe reaction to a “peanut test” after taking the drug. For the placebo arm, that number was 4%.
DBV, though, has been favorably viewed by analysts for its safety. The open-label extension to DBV’s trial showed improved effectiveness over the initial readouts. And, although there have been no direct head-to-head trials, patients have consistently tolerated their therapy, called Viaskin Peanut, better than they have Aimmune’s Palforzia.
“Despite slower onset of desensitization, we continue to view Viaskin Peanut as a safer and more pt.-friendly therapeutic alternative to oral immunotherapies (OIT) like Palforzia,” SVB Leerink’s Joseph Schwartz wrote in a note to investors earlier this month.