In another win for rival Aimmune, FDA presses pause on DBV's peanut patch with additional questions
Another regulatory setback has strayed DBV Therapeutics’s peanut allergy patch off the path to approval.
On Monday, the company disclosed that the FDA, which is currently reviewing the marketing application for the patch, had questions regarding the patch’s adhesion and efficacy concerns if the patch was not fully adhered to the patient’s skin. Consequently, the FDA advisory committee meeting scheduled for May 15 will not be taking place — although no changes to the FDA’s action date of August 5 were announced.
DBV already has the data necessary to answer the FDA’s questions, has previously found that patch adhesion did not have a significant impact on clinical efficacy and is confident that no additional studies will be required, it said in a conference call following the press release.
“Though DBVT may satisfy FDA’s questions with supplement data in hand (submission timing uncertain), we expect a further delay in potential approval (from Aug.), particularly as it’s being reviewed at the same division working on COVID-19 vaccines,” Jefferies analysts said.
Baird’s Brian Skorney has long suggested that given rival Aimmune’s Palforzia approval, DBV’s “there is nothing else available” argument for its peanut allergy patch — and its comparatively weaker efficacy profile — will prevent it from passing muster at the agency.
“(A)t this point we view DBVT as effectively dead in the water,” he wrote in a note. “We continue to anticipate FDA will not approve this therapy, which could potentially make Aimmune’s Palforzia the only FDA-approved peanut allergy therapy for the foreseeable future.”
Skorney expects the new coronavirus could also impact the near-term launch of Palforzia.
DBV and Aimmune were initially locked in a race to the finish line to market their peanut allergy treatments in the United States. Aimmune effectively leapfrogged DBV when the latter rescinded an application to market its Viaskin Peanut patch in 2018 in response to FDA concerns about the state of manufacturing and quality control data submitted. In early 2020, the FDA sanctioned the use of Aimmune’s therapy.
Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. In a bid to build up some immunity, some physicians have also been dosing patients with peanut powder orally, albeit off-label.
DBV’s Viaskin Peanut is a patch applied daily to the upper back that delivers peanut antigen to desensitize the patient. The patch must be worn for longer periods as time passes and used every day to maintain desensitization. Palforzia is effectively peanut flour, which must be mixed into pudding, applesauce or other foods. Dosing is escalated gradually, and the therapy must be continued daily to maintain desensitization.
Based on surrogate outcomes — oral food challenges — Palforzia appears to be more effective than Viaskin Peanut, but carries more adverse effects, cost-effectiveness watchdog ICER concluded in its analysis last year.