DBV Technologies Provides Update on Investigational Viaskin Peanut for Children Ages 4-11 Years

Nachrichtenquelle: globenewswire
14.01.2021, 22:30  |  235   |   |   

Montrouge, France, January 14, 2020

DBV Technologies Provides Update on Investigational Viaskin Peanut for Children Ages 4-11 Years

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the receipt of written responses from the U.S Food and Drug Administration (FDA) to questions provided in the Type A meeting request the Company submitted in October 2020.  The Type A meeting request was submitted following the Company’s receipt of a Complete Response Letter (CRL) in connection with its Biologics License Application (BLA) for Viaskin Peanut (DBV712), an investigational, non-invasive, once-daily epicutaneous patch to treat peanut allergy in children ages 4 to 11 years.

DBV believes that the feedback received from the FDA provides a well-defined regulatory path forward. In exchanges with the FDA, DBV proposed potential resolutions to two main concerns identified by the FDA in the CRL: the impact of patch adhesion and the need for patch modifications. DBV will address details about a new human factor (HF) validation study and additional chemistry, manufacturing and controls (CMC) data in subsequent interactions with the FDA.

The FDA agreed with DBV's position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 one peanut) remains unchanged and performs in the same way it has performed previously.

In order to confirm the consistency of efficacy data between the existing and modified patches, FDA has requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess the modified Viaskin Peanut patch in the intended patient population.

DBV plans to initiate the selection of modified prototype patches in the first quarter of 2021. Additionally, DBV will submit the protocol for the safety and adhesion trial in children with peanut allergy to FDA for review and comments in the second quarter of 2021 before initiating the trial.

We are very encouraged by the positive feedback received from the FDA, and we appreciate the clarity provided,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies. “I want to thank the DBV team for their dedication in working to address the FDA’s findings over the past few months. We intend to advance a remediation plan for Viaskin Peanut and work closely with FDA to review protocols and re-file our BLA as soon as possible, so that we can bring Viaskin Peanut, if approved, to patients suffering from peanut allergies.

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DBV Technologies Provides Update on Investigational Viaskin Peanut for Children Ages 4-11 Years Montrouge, France, January 14, 2020 DBV Technologies Provides Update on Investigational Viaskin Peanut for Children Ages 4-11 Years DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage …

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