Shares of DBV Technologies (DBV) climbed higher after it announced the receipts of written responses from the FDA to the question asked for the Type A request the company submitted in Oct 2020. DBV applied for a Biologic Licenses Application for its Viaskin Peanut (DBV712), a non-intrusive hypodermic patch that helps treat peanut allergy in children aged 4-11 years.
The French-based biopharmaceuticalcompany believes that the feedback provided by the FDA results in a well-designed path forward. Two main concerns were suggested by the FDA in the recent patch investigation. These are the impact of patch adhesion and the need for patch modification. DBV will address these issues down the road regarding its validation study and manufacturing controls with the FDA.
What is DBV?
DBV Technologies SA is a publicly owned French-based biopharmaceutical firm headquartered in Bagneux, France. It is known for developing “Viaskin” technologies for administering allergens to the skin, avoiding no transfusion of blood. Currently, the patch has received Fast Track Designation from the FDA. Considered to be an innovative process, the ready-to-use patch is highly reliable as it conserves the allergy. This helps the patient to tolerate exposure to peanuts, thus lowering the risk of a systematic and allergic reaction in the event of exposure.
What DBV targets?
Peanut allergy is one of the most common and versatile food allergies. This can lead to severe and potential allergic reactions. For this sole reason, DBV is developing a one-kind patch to deal with allergies, which is very common in kids aged 4-11. Viaskin Peanut Patch will be 250 µg and no changes will be made regarding its dosage. The FDA has suggested conducting a recommended 6-month command-and-control trial to assess the feasibility of the patch to the intended patient population.
DBV is currently starting this trial in the first quarter of 2021. Based on the received guideline parameters set by the FDA. DVB plans to implement such guidelines that keep overhead cost measures to a minimum.