Neuren Pharmaceuticals has announced that its licensee, Acadia Pharmaceuticals, received a negative trend vote from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The vote concerns Acadia’s marketing authorisation application for trofinetide, a treatment for Rett syndrome, in the European Union. Neuren Pharmaceuticals focuses on developing and commercialising novel therapies to treat neurological disorders. Acadia Pharmaceuticals is the licensee responsible for seeking regulatory approval for trofinetide in specific regions.
The negative vote follows Acadia’s recent oral explanation to the CHMP. A final decision is expected when the CHMP formally adopts its opinion in February. Should the final opinion remain negative, Acadia plans to request a re-examination of the CHMP decision, in accordance with EU regulations. These rules allow a 15-day window to seek such a re-examination.
Neuren’s chief executive officer, Jon Pilcher, expressed his disappointment with the vote, describing it as “frustrating.” Despite the setback, Pilcher affirmed the company’s full support for Acadia’s planned re-examination. He emphasised Acadia’s dedication to ensuring trofinetide becomes available to patients suffering from Rett syndrome within the European Union.
The availability of trofinetide in Europe is very important for Neuren. The company continues to back its licensee through the regulatory process. Neuren hopes Acadia can successfully navigate the re-examination process.
