DBV Announces Regulatory Updates For The Viaskin Peanut Patch In The U.S. And Europe; BLA Submission Under Accelerated Approval Is Subject To Completion Of A 6-Month Supplemental Safety Study In Toddlers To Be Initiated In Q2 2025; VITESSE Phase 3 Study Evaluating The Viaskin Peanut Patch In Children Ages 4 – 7 Years-old Exceeded Enrollment Goals
Portfolio Pulse from Benzinga Newsdesk
DBV Technologies announced regulatory updates for its Viaskin Peanut Patch in the U.S. and Europe. The company plans to pursue accelerated approval for toddlers in the U.S., contingent on a safety study starting in Q2 2025. The VITESSE Phase 3 study for children aged 4-7 exceeded enrollment goals, with results expected in Q4 2025. The EMA has confirmed the registration path for a Marketing Authorization Application in Europe.
October 22, 2024 | 8:48 pm
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DBV Technologies is advancing its Viaskin Peanut Patch with positive regulatory updates in the U.S. and Europe. The FDA has provided guidance for accelerated approval for toddlers, pending a safety study. The EMA has confirmed the registration path for a broader age range in Europe.
The news indicates significant regulatory progress for DBV Technologies, which could positively impact its stock. The FDA's guidance for accelerated approval and the EMA's confirmation of the registration path are crucial steps forward. The successful enrollment in the VITESSE Phase 3 study further supports the company's development efforts.
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