Catalyst Requests FDA extend use of Firdapse to children
Good morning all!
Yesterday Catalyst announced that they have requested the FDA to extend approval of Firdapse to include children! This would eliminate the need to apply to the expanded access program to receive Firdapse for children under 17.
“Catalyst plans to submit a pediatric supplemental new drug application to the FDA this year that might expand Firdapse’s approval to children with LEMS. The company also is planning to seek approvals or expanded approvals outside the U.S., starting in Japan and Canada,” according to the article on Lambert- Eaton News.
So far, a date hasn’t been released for when they expect this to happen, but stay tuned and we’ll let you know as soon as we know anything!
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