After reviewing the FDA's information requests and considering all other options, DBV Technologies has decided not to pursue the sequential approach to develop Viaskin Peanut (allergen uptake/transport study before STAMP).
- DBV estimates that heeding to the FDA's newly proposed sequential approach would require at least five rounds of exchanges requiring FDA alignment before initiating STAMP, a 6-month safety, and adhesion study.
- Instead, DBV will initiate a Phase 3 study for a modified Viaskin Peanut patch in children in the intended patient population.
- The study will feature the modified Viaskin Peanut (mVP) patch, which is circular in shape and approximately 50% larger than the current Viaskin Peanut (cVP) patch.
- The Company is finalizing the protocol and expects to submit the protocol to the FDA by the end of February 2022.
- DBV Technologies has also decided to withdraw the European marketing application Viaskin Peanut.
- At the time of the withdrawal, it was under review by the EMA's Committee for Medicinal Products for Human Use (CHMP).
- Price Action: DBVT shares are down 25.90% at $2 during the premarket session on the last check Tuesday.
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