Health Canada has accepted Mitsubishi Tanabe Pharma Corporation’s New Drug Submission (NDS) for edaravone to treat patients with amyotrophic lateral sclerosis (ALS). Health Canada has also granted the drug a Priority Review so that it should take less than 6 months for the review process to be completed.
Anyone who has participated in the Canadian healthcare system understands that it is complicated. And like many endeavours, the more government agencies involved, the more complicated (and convoluted) it seems to get. The same is true for the approval and disbursement of new medicines.
In June 2016, the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee approved the use of Ilaris (canakinumab) to treat children with systemic juvenile idiopathic arthritis (SJIA), not responding well to other treatments. As with many CADTH reviews, this one came with a caveat.
In January 2016, Health Canada approved the use of Orkambi (lumacaftor/ivacaftor) for the treatment of patient with cystic fibrosis (CF) who had 2 copies of the F508del mutation in their CFTR gene. That was the beginning of the regulatory roller coaster that the CF community has been through the past 2 years.
In May 2017, Health Canada approved Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC). More specifically, the drug was approved in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Once a drug is approved by Health Canada, the next step is for the drug company to submit information about the drug’s efficacy, safety, and pricing to the Canadian Agency for Drugs and Technologies in Health (CADTH) as well the various provincial health ministries. The agencies will also accept patient groups’ input.