(BFM Exchange) – While the prospect of approval for its flagship product has eluded for years, the biopharmaceutical company has concluded that a new phase 3 study is the best way to finally get sesame from the health authorities. DBV is also withdrawing the application for registration (MA) of Viaskin Peanut in Europe.
DBV Technologies’ course change on how to get approval for its Viaskin Peanut anti-peanut patch is not well with investors. “In October, we were surprised to see that the FDA required a consistent approach to our development plans,” recalls DBV Technologies CEO Daniel Tasse, who was quoted in a statement released by the group on Tuesday morning, adding that the group is “convinced that the new A key phase 3 study generating a robust data set is the best way to support the development of Viaskin Peanut.”
Specifically, the U.S. Food and Drug Administration has asked DBV for more information about Viaskin Peanut, a patch designed to treat children with a peanut (peanut) allergy that affects more than one million patients in the United States. In particular, the FDA urged DBV to take a consistent approach, wanting to review the protein release study data before making further comments on the design of the STAMP protocol for “Safety, tolerability, and adhesion of modified patches.” which should check the harmlessness and local adhesion of the plasters.
This patch, which was the subject of a pilot study in 2013, has been repeatedly challenged by the FDA (the share price has fallen over 90% since its October 2017 record of over €85, two months after the Phase 3 clinical trial began) .
Therefore, despite a tumultuous relationship with the FDA, DBV chose to ignore the agency’s (admittedly changing) recommendations, arguing that “adopting the sequential approach recently proposed by the FDA would require at least five exchange cycles requiring FDA approval before initiating STAMP ( …) DBV believes that this approach is not in the best interests of patients.”
“Based on the advice and requests for information received from the FDA regarding STAMP in October and the allergen uptake/transfer study in November, the Company believes that further communication with the FDA in the context of resource dependency review delays will be unpredictable and likely to result in significant delays in our regulatory progress,” says Daniel Tasse.
Therefore, biotech indicates that it has chosen a different approach “after carefully considering requests for information from the FDA and exploring all other options,” and recalls that it planned to conduct the studies requested by the US authorities.
DBV says it has informed the FDA of its intention to initiate a new pivotal phase 3 clinical trial of a modified Viaskin Peanut patch in children in a targeted patient population. Biotechnology considers this approach “the most direct and effective way to advance and advance the regulatory pathway of Viaskin Peanut” and also considers it “the most direct way to demonstrate the efficacy, safety, and improved adhesion of modified Viaskin in vivo.” Peanut System.
“The Food and Drug Administration confirmed that the DBV strategy change was acceptable in oral and written exchanges,” tricolor biotech clarifies.
Therefore, the study in question will focus on the modified Viaskin Peanut (mVP) patch, which is round and approximately 50% larger than the current Viaskin Peanut (cVP) patch. “In the CHAMP study, conducted in a group of healthy adults, mVP outperformed cVP. The new pivotal study will also include updates regarding instructions for use,” DBV clarifies.
“In late November 2021, DBV received advice and requests for information from the FDA regarding the assessment of comparability of allergen uptake/transport between mVP and cVP. After reviewing these reports, it is clear that additional discussions with the FDA will be required before DBV can initiate a study comparing allergen uptake between mVP and cVP,” DBV continues. Its general manager, Daniel Tasse, however, says he remains “convinced that Viaskin Peanut represents a viable treatment option for currently poorly cared for patients who are looking forward to treatment options.” “Our priority is to provide them with a safe, effective and practical product as soon as possible,” he concludes.
DBV Technologies also announced on Tuesday that it has “officially notified the European Medicines Agency (EMA) of its decision to withdraw its marketing authorization (MA) application for Viaskin Peanut” while the product is under development. Human products (CHMP). This decision to withdraw was based on the current opinion of the CHMP that the data available to date from a single pivotal study in the marketing authorization is insufficient to avoid a day 180 review process of a serious objection regarding, for example, clinical significance. and the magnitude of the effect. “DBV’s decision to withdraw the marketing authorization for Viaskin Peanut is the result of careful consideration aimed at making the highest possible application for patients in the European Union,” said DBV Technologies Medical Director Faris Mohidin.
In the stock market, this Viaskin Peanut regulatory update resulted in a sharp price drop of 18% to €4.02 for the title, which left SBF 120 on December 10 in favor of OVHCloud. As such, DBV Technologies has fallen to its lowest since November 2020 and the group’s valuation has fallen to around 220 million euros.
Quentin Subrann – © 2022 BFM Bourse