The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending European Union (EU) marketing authorisation for DAYBU®(trofinetide) following a re-examination procedure.

Neuren CEO Jon Pilcher commented: “I am so delighted for all stakeholders to see this positive outcome from the CHMP re-examination process recommending marketing authorisation for DAYBU® in the EU. With no approved treatment currently available in the EU, approval of DAYBU® would represent an important step forward for patients, caregivers and the wider Rett syndrome community profoundly impacted by this devastating condition.”