DBV Technologies was hit hard a few months back when it was forced to pull its FDA filing for peanut allergy therapy Viaskin Peanut. Now, it’s having a second attempt.
The French biotech has submitted a new dossier to the FDA seeking approval for the product as a treatment for peanut-allergic children aged four to 11 years, as it tries to catch up with a rival programme from US company Aimmune Therapeutics that is already under FDA review.
Both candidates have breakthrough status, meaning that they will be granted speedy reviews and, unless there is another mishap, Aimmune should now get its AR101 therapy to the US market first with a label covering the four to 17 age range.
Aimmune is expecting an approval decision on AR101 by January 2020, and the FDA has planned an advisory committee meeting to discuss the drug in September. The US company also seems to be in the lead in Europe, with a filing there due in the next few months.
Viaskin Peanut is a patch worn on the skin that delivers peanut allergens in a controlled manner to stimulate immune tolerance, while Aimmune’s drug is given orally. The two are being held up as potential life-saving therapies for the estimated six million people with this allergy in the US and Europe alone.
The withdrawal of the marketing application came after the FDA expressed concerns about manufacturing. DBV says its new filing “incorporates additional data needs on manufacturing procedures and quality controls” requested by the agency.
GlobalData has predicted that Aimmune’s drug will have two-thirds of the market in 2027, with DBV’s drug claiming around a third and other players such as Prota Therapeutics and Camallergy playing minor roles. Meanwhile, Clarivate Analytics thinks AR1010 will makes sales of almost $1.2bn at its peak.
“This is an important milestone for DBV, as we are one step closer towards potentially bringing Viaskin Peanut to patients,” said the company chief executive Daniel Tassé.
”Everyone at DBV is highly committed to potentially addressing the significant unmet medical need facing peanut-allergic patients,” he added.