Catalyst Pharmaceuticals submits NDS to Health Canada for Agamree

Kye Pharmaceuticals announced it has submitted a New Drug Submission, or NDS, to Health Canada for the regulatory review and approval of AGAMREE, or vamorolone. If approved, AGAMREE would be the first and only therapy approved by Health Canada with an indication for the treatment of Duchenne muscular dystrophy, or DMD. Health Canada has granted AGAMREE a priority review and marketing authorization could be granted before the end of 2025. News of the AGAMREE priority review was welcomed by national patient organizations. The Canadian Neuromuscular Disease registry estimates that there are more than 800 boys and young men living with DMD in Canada and coping with its debilitating symptoms.