DBV Technologies (DBVT) announces results from a three-year open-label extension, PEOPLE, of the Phase 3 PEPITES study evaluating Viaskin Peanut in children with peanut allergy. The data were just published in The Journal of Allergy and Clinical Immunology.
Participants experienced sustained clinical benefit with an additional two years’ treatment with Viaskin Peanut.
75.9% (n=107/141) showed an improvement in eliciting dose (ED) from baseline at month 36.
51.8% (n=73/141) achieved an ED of at least 1,000 mg at month 36.
Mean cumulative reactive dose was 1,768.8 mg (median: 944 mg) at month 36 compared to 223.8 mg (median: 144 mg) at baseline.
The treatment effect was observed across a range of baseline activity, including the most sensitive patients.
77.8% (n=14/18) of a subset of patients were able to maintain desensitization for a two-month period while off therapy and without peanut consumption.
The company’s U.S. marketing application is currently under FDA review with an action date of August 5, although about four months ago the company reported that the review team identified “questions” concerning efficacy and canceled the scheduled advisory committee meeting. It said that it was “communicating” with the agency about additional information on patch-site adhesion and data from the extension study.
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