Since the announcement that the phase 2 trial with TAK-611 for children with Metachromatic Leukodystrophy has not met any of its primary or secondary objectives, Takeda Pharmaceuticals has been actively engaged in discussions and listening to feedback from investigators, families and the patient advocacy community regarding the programme.
A spokesperson, for Takeda said, “It is clear to us that the families of the children in the trials have expressed a sincere desire to continue receiving TAK-611. For this reason, we have taken the decision to extend the ongoing TAK-611 clinical trials (HGT-MLD-071 and SHP611-201) until further notice”. This is for children who have already participated in the trial.
Evaluating its options
During the extension of the study, Takeda will work with regulatory authorities, investigator sites and the MLD community to evaluate options for continued access, with the goal of overcoming barriers and establishing long-term access to TAK-611 that meets the treatment demands of patients and families.