ABSTRACT
Phase 3 clinical testing of Rebif® began in Canada during the spring of 1994, leading ulti mately to approval of Rebif® at two doses for patients with relapsing-remitting multiple scler osis (RRMS). The drug was approved for use in 1998 and covered both relapse and disability indications in the target population. The approval process as outlined below was relatively rapid, requiring only 24 months, for a standard application. Other products approved for mul tiple sclerosis (MS) in Canada include Betaseron®, approved via a fast-track applica tion, Copaxone®, and Avonex®. Canada is the first country in which approval was granted for all four disease-modifying therapies in MS. The details of approval for Rebif® are summarized to describe the drug approval process in Canada.
