Three Years After FDA Rejection, DBV Finds New Path for Peanut Allergy Patch

Pharis Mohideen knows all too well how unforgiving the world can be for people with food allergies. As the father of two children with severe peanut allergies, Mohideen still remembers the measures he and his wife took to keep their children safe—from moving to a school district with better accommodations to giving up long-haul flights for fear of touching contaminated surfaces.

"I didn't go home to Hawaii for almost four years because we were so afraid of not being able to handle a situation during a flight," Mohideen recalls. "The doctors told us your son's allergy is extremely severe, and that scared us."

In 2018, when DBV Technologies, a clinical-stage biotech company focused on pediatric food allergy therapies, had an opening for Chief Medical Officer, Mohideen seized the opportunity without hesitation.

Under the leadership of then-Chief Scientific Officer Dr. Hugh Sampson—a highly respected allergy researcher—the company was developing an epicutaneous immunotherapy (EPIT) patch designed to reduce the severity of allergies in children. The peanut indication was the primary focus, but the company was also studying the technology for other conditions, including pediatric milk allergy.

For Mohideen, who had a background in clinical development at large pharmaceutical companies Bristol Myers Squibb and Novartis, the value of the Viaskin technology was clear.

"I told them, I'm not an allergist—if you need an allergist, don't hire me," he says. "But if you need someone who has lived through 20 years as a father and is willing to pour his heart into this company because I've been through it and know what it means to patients, then I'm your guy."

However, less than a year into Mohideen's tenure, DBV faced an unexpected setback: the FDA issued a Complete Response Letter for its treatment for children aged 4 to 11. Mohideen admits it was a "heavy blow," but it did not shake his or the team's determination to push the product through.

Subsequent challenges also failed to stop them—redesigning the patch, communicating with the FDA during the global pandemic, and watching competitor Aimmune's product gain less market acceptance than expected, which shook industry investment confidence.

Now, that persistence may finally pay off. With positive Phase III trial results for patients aged 1 to 3 published earlier this year in the New England Journal of Medicine, Mohideen finally sees a "clear path" for DBV's peanut patch to gain approval and ultimately become profitable.

The Road to Breakthrough

The FDA's rejection of DBV's therapy came in August 2020, just months after the regulatory agency approved Aimmune's peanut powder therapy Palforzia to reduce adverse reactions from accidental exposure. In the Complete Response Letter, the FDA cited concerns that too many patches were falling off patients, potentially affecting efficacy.

Over several years, DBV worked with the FDA to redesign the product from a square patch to a round one, while maintaining the same dose of 250 micrograms of peanut protein—equivalent to one-thousandth of a peanut kernel. Based on data analysis showing better treatment response in younger patients, the company also narrowed the age range from 4 to 11 down to 4 to 7.

The only obstacle was timing, Mohideen says. DBV was communicating with the same FDA division responsible for reviewing COVID products, so "things didn't go as smoothly as expected."

Despite the setback, DBV launched a new 12-month placebo-controlled efficacy trial in March of this year, along with supplemental safety studies as required by the FDA. Overall, Mohideen says he "expects top-line data around mid-2025" for the 4-to-7 age group.

Meanwhile, Phase III results published earlier this year for patients aged 1 to 3 using DBV's original square patch showed that after treatment, toddlers with more severe allergies could tolerate exposure to peanut protein equivalent to one peanut kernel, while those with milder symptoms could tolerate three to four.

"We were ecstatic about that data," Mohideen says. "We didn't need to do another efficacy study—the FDA reviewed the data and said: 'Just give us a six-month supplemental safety study.'"

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"You put on the patch and go about your daily activities. Whether you're sick or something else happens, it doesn't matter."

Pharis Mohideen

Chief Medical Officer at DBV Technologies

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Although DBV is still finalizing details with the FDA, Mohideen expects the trial to take a year from enrollment to completion, followed by about 11 to 12 months before the FDA makes a decision.

Given that main competitor Palforzia has been on the market for three years, this timeline might seem lengthy. But Mohideen believes the key differences in delivery mechanisms between the two therapies, combined with the potential approval of Viaskin Peanut for younger children, leave ample room in the market.

"We don't need them to fail for us to succeed," he says.

A Fragile Market

However, Palforzia has not lived up to its once-blockbuster expectations.

When the product launched, food giant Nestlé made a heavy bet, acquiring it from Aimmune Therapeutics in 2020 for over $2 billion. But market demand for the drug never reached such high expectations, and earlier this month, Nestlé sold Palforzia at a loss to Swiss peer Stallergenes Greer.

One explanation experts give for Palforzia's underperformance is the time commitment required from parents of patients aged 4 to 17. Patients on the therapy need frequent clinic visits to gradually increase doses of peanut powder, offering a more standardized approach to the "home-made" immunotherapy often prescribed by allergists.

This is where Mohideen believes DBV's therapy has a major advantage—ease of use.

"It's basically a patch applied to the child's back every day," he explains. "You put it on and live your life. Whether you're sick or not, it doesn't matter."

And the market potential for the product is enormous. About 1.5 million children under 17 in the U.S. have a peanut allergy. According to DBV's estimates, about 100,000 severely allergic patients in each age group are eligible for treatment, meaning about 300,000 patients aged 1 to 3, with another 400,000 aged 4 to 7.

The main hurdle, Mohideen says, is convincing stakeholders of the drug's necessity, since it only reduces the severity of the allergy rather than eliminating it entirely.

"I spoke with a regulator in Europe who didn't quite see the value of the product because he said: 'After wearing it for three or four years, what's next?'" Mohideen recounts.

"I told him, if you have a 1-to-3-year-old crawling around putting everything in their mouth—if you can provide protection for that toddler until they're 6, 7, 8 years old with better brain development and cognitive abilities, you've added a layer of protection that didn't exist before."

Although Mohideen's children are no longer young—both are in their twenties—he says that enhanced sense of safety would have changed many aspects of their upbringing.

"These are things they didn't consider, but as a father who's been through it, [I know] at that age, you just want them to grow into a stage where they understand the condition," he says.