(AOF) – DBVTechnologies has officially notified the European Medicines Agency (EMA) of its decision to withdraw the Marketing Authorization (MA) application for Viaskin Peanut. The application for Viaskin Peanut had been accepted by the EMA in November 2020. At the time of the withdrawal, the product was under review by the EMA’s Committee for Medicinal Products for Human Us (CHMP). The initial filing was supported by positive data from a single pivotal phase 3 trial, Pépites (V712-301).
The withdrawal decision was based on the current opinion of the CHMP that the data available to date from a single pivotal study in the Marketing Authorization was not sufficient to avoid, on day 180 of the review process, a major objection.
As noted earlier, the major objection concerns the scope of the data, for example, clinical relevance and magnitude of effect. DBV believes that the generation of data from a new pivotal phase 3 trial will pave a more robust path for the approval of Viaskin Peanut in the European Union.
“DBV’s decision to withdraw MA for Viaskin Peanut is the result of careful consideration to submit the strongest possible claim for patients in the European Union,” said Pharis Mohideen, Medical Director of DBV Technologies .
“Our team has demonstrated thought and analysis in designing a new pivotal Phase 3 trial protocol to support US and European regulatory pathways, and we will continue to work closely with the EMA at as we produce additional data, “said the medical director.
LEXICON
Clinical trials (Phases I, II, III)
Phase I: testing of the molecule on a small scale in humans to assess its safety, tolerance, metabolic and pharmacological properties. Phase II: safety and efficacy evaluation on several hundred patients to identify side effects. Phase III: evaluation of the overall benefit / risk ratio in several thousand patients.
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Boost for French pharmacy
At the end of a recent CSIS, the French authorities announced an unprecedented amount of credits (7 billion euros): 1.5 billion for university hospital research, 2 billion for investment in health via bpi France , 1.5 billion in aid for the relocation of industrial projects, and 2 billion to strengthen investment in three sectors of the future (bioproduction, digital medicine, and pandemic preparedness). In addition, the annual growth in drug expenses reimbursed by Medicare will be 2.4%, which should generate growth of at least 0.5% in laboratory turnover,
Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the actual benefit is sufficient.