Biogen has shared a letter to the FA community that includes a summary of recent advances in the SKYCLARYS program, such as the recent approval of SKYCLARYS by the European Commission as well as the addition of sprinkle administration to US prescribing information.
Biogen has also shared its plan to initiate a small phase 1 clinical trial in the FA pediatric population and its commitment to engaging regulators and refining their FA pediatric development plan. FARA continues to work with Biogen to bring the patient voice and sense of urgency to the process.