DBV Technologies fall, setback for Viaskin Peanut in Europe

PARIS, December 21 (Reuters) – DBV Technologies unscrews Tuesday on the Paris Stock Exchange after asking the European Medicines Agency (EMA) to withdraw its application for marketing authorization for Viaskin Peanut, its flagship experimental treatment peanut allergy.

At 10:30 am, the biopharmaceutical company, which left the SBF 120 index on Monday, fell 17.98% to 4.017 euros, its lowest for a year.

In a statement released Monday evening, DBV indicates that its decision is based on the opinion of the AEM’s Committee for Medicinal Products for Human Use that the data available to date from a single pivotal study is not sufficient to prevent a major objection.

“DBV’s decision to withdraw the marketing authorization for Viaskin Peanut is the result of careful consideration aimed at submitting the strongest possible application for patients in the European Union,” said Pharis Mohideen, medical director of the group which intends to launch a new phase III study to ultimately obtain the green light from the European and American authorities.

The DBV share had climbed by around 53% on November 2, 2020 after the validation of the filing of its application for authorization of Viaskin Peanut by the European agency. (Report Laetitia Volga, edited by Blandine Hénault)