MaaT Pharma: CHMP Likely to Issue Negative Opinion on Xervyteg
Lyon-based biotech company MaaT Pharma has been informed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency of a trend towards a negative opinion regarding its application for conditional marketing authorization for Xervyteg (MaaT013), a treatment for acute graft-versus-host disease. The formal CHMP vote is expected in June.
Negative Trend Before June Vote
During an oral hearing before the EMA's CHMP, MaaT Pharma was notified of a trend towards an unfavorable opinion for Xervyteg in the treatment of acute graft-versus-host disease (aGvH). The formal committee vote is scheduled for the June meeting. The company indicates that this feedback reflects the expected challenges for a first-generation drug based on a new therapeutic approach, including a single-arm pivotal trial. Subject to the formal CHMP vote, MaaT Pharma plans to request a re-examination of the file, a procedure that allows for a new independent scientific assessment by a separate group of reviewers.
Regulatory Timeline and Financial Resources
The EMA expects that the re-examination of the file will take place within 60 calendar days after receiving the formal request from the company. MaaT Pharma has implemented cash management measures to extend its financial visibility until November 2026, from initially August 2026, in order to cover the next regulatory steps, including the re-examination procedure, while continuing the development of its pipeline. Xervyteg is evaluated under the conditional marketing authorization procedure, designed to facilitate faster access to treatments that meet an unmet medical need, while allowing for the generation of confirmatory post-authorization data.
Clinical Data Supporting the Candidate
Xervyteg is supported by data from the pivotal ARES trial, as well as real-life data from the ongoing compassionate access program in 13 countries, which has treated more than 300 patients since 2019. These data have been presented at major international congresses and published in peer-reviewed scientific journals. Hervé Affagard, CEO and co-founder of MaaT Pharma, stated he remains strongly convinced of the registration potential of Xervyteg and remains fully committed to working closely with the EMA to advance the file, encouraged by the potential of this therapy to meet a major unmet medical need in patients with acute aGvH.
