STAT+: In an about-face, Health Canada allows a controversial rare disease drug back on the market
In yet another twist in a complicated tale, Health Canada has reinstated approval of a rare disease drug after the manufacturer of a rival medicine claimed the regulator had originally issued an “incorrect and unreasonable” endorsement.
The move came after Canada’s Federal Court earlier this month quashed the approval for Ruzurgi, which is used to treat people with a rare neuromuscular disorder called Lambert-Eaton myasthenic syndrome, or LEMS. The medicine is marketed by Jacobus Pharmaceuticals, a small, family run company, although a competitor, Catalyst Pharmaceuticals (CPRX), has sought to push back the approval until 2028.
