Here’s the Update…
DBV Technologies (DBVT) stock rose 35.3% to $5.5in the premarket session after a biotech clinical-stage firm has stated that it has obtained written answers from the United States Food and Drug Administration (FDA) to the questions sent by the company to the Form A meeting in October 2020.
After obtaining a Complete Response Letter (CRL) for its Biologics License Application (BLA) for Viaskin Peanut (DBV712), the organization received a Type A meeting order for a study, non-invasive, once regular epicutaneous patch for the treatment of peanut allergy in children aged between four and 11 years.
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DBV claims that FDA feedback offers a well-defined regulatory direction. DBV suggested future resolutions in exchanges with the FDA to two major issues listed by the FDA in the CRL: the effect of patch adhesion and the need for patch improvements. In subsequent communications with the FDA, DBV will discuss specifics of a recent validation analysis for human factors and supplementary evidence on chemical engineering, production, and controls.
The FDA has agreed with DBV’s opinion that the improved Viaskin Peanut patch must not be treated as a new product agent if the original Viaskin Peanut patch’s occlusion chamber and the peanut protein dosage of 250 μg (round 1/1000 one peanut) are unchanged and usable.
FDA also called for an investigation evaluating the use of allergens (peanut protein) between the patches of allergic peanut children aged 4-11 to confirm the accuracy of effectiveness evidence between the current and updated patches. FDA has suggested that the updated Viaskin Peanut patch be conducted in the targeted patient group for a 6-month, well-monitored safety and adherence trial.
DBV Technologies is working on Viaskin, an experimental platform with potential application in immunotherapy. The Viaskin method is modeled after epicutaneous immunotherapy, which DBV has developed to deliver biologically active compounds to the immune system through intact skin. The company’s mission is to safeguard food allergic patients with these new non-invasive product candidates.
Analysts hold a lot of potential for biotech stocks. However, those biotechs may fail in clinical trials, even if they do well in testing. Investments in biotech stocks can come with the significant risks of money running out, companies needing to pay for clinical studies, completing regulatory filings, and bringing new products to market.