(News Bulletin 247) – The biotechnology company announced Wednesday evening that it had agreed with the American health authority on the approval process for this patch to treat peanut food allergy in very young children.

DBV Technologies is on fire on the Paris Stock Exchange this Thursday. The biotechnology company, whose market capitalization was close to 2 billion euros at the time of its splendor in 2017, takes 25% around 12 p.m.

The company announced progress on its dialogue with the Food and Drug Administration (FDA) regarding the accelerated approval process for Viaksin Peanut. This product is a patch which should help treat food allergy to peanut in children, particularly in very young children, aged one to three years.

This patch must undergo an accelerated validation procedure in the United States. To do this, the treatment must satisfy three criteria: it must treat a serious disease, provide a significant advantage compared to available therapies and “demonstrate an effect on an intermediate clinical criterion which is reasonably likely to predict a clinical benefit”.

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Towards a license application in 2026

The patch already satisfies the first two criteria. Discussions between DBV and the FDA have focused, in recent weeks, on the third point, and the steps to be taken to meet the third criterion.

“In its recent written communication, the FDA confirmed that the efficacy data from the company’s Phase 3 EPITOPE study (the last step before marketing, Editor’s note) could serve as an interim clinical endpoint. The FDA also agreed that the endpoint is reasonably likely to predict clinical benefit and will therefore qualify for accelerated approval,” DBV explained.

The company and the FDA also agreed on the key elements of the “COMFORT Toddler” study, which aims to obtain additional data on the safety (absence of risks) and adherence of the patch in older children. from one to three years old and allergic to peanuts.

“The COMFORT Toddlers study will bring to 600 the total number of subjects exposed to the Viaskin Peanut patch for at least 6 months in a controlled study, as required by the FDA. In total, approximately 240 subjects will have worn the patch clinical in the EPITOPE study and 360 subjects the commercial patch in the COMFORT Toddlers study”, explains DBV Technologies.

DBV and the FDA also agreed that the company will conduct a post-marketing confirmatory study that will demonstrate the effectiveness of the patch. This last study must be launched at the time of filing the BLA, that is to say the biological license application. What the company plans to do during the second half of 2026 is for Viaskin Peanut in children aged one to three years.

“DBV is pleased to have received what we believe to be a clear and reasonable regulatory path for accelerated approval of the Viaskin Peanut patch in children aged 1 to 3 years,” said Daniel Tassé, CEO of DBV Technologies. , quoted in a press release.

“We believe we have thus minimized the risk associated with the regulatory path of our programs and can now focus on executing studies that will support two BLAs for two distinct age groups in the United States and a Marketing Authorization (MAA). market) in Europe,” he added.