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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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2 Replies
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It appears they want to dominate the market with Firdapse and edge out Jacobus out of business. Let Ruzurgi have a portion of the market. I wish there was a way I could get back on Ruzurgi, it worked better for me. They should allow patients that started on Ruzurgi be allowed to continue on it instead of being forced to change.
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Hi @gary-chudd
I’m sorry you feel that way. With orphan drugs, there is a clause that allows them to have “market exclusivity,” and Jacobus tried to go around this.
Catalyst put a big investment in getting Firdapse approved, and did many studies (which also cost $$) to prove the drug was effective for LEMS in order to get FDA approval. Jacobus did not, although they did provide the drug at no cost. If it wasn’t for the FDA approval many LEMS patients, like myself, did not have access to the medication. The “expanded access” program required physicians that prescribe to be approved by them and submit a lot of paperwork, which many were unwilling to do, including my neuro at the time.
I do not like to talk politics here on the forum, so please be respectful.
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