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Trikafta, cystic fibrosis ‘miracle drug’, one step closer to being approved in Canada

Canadians living with cystic fibrosis (CF) are in celebration mode, as what’s been described as a life-saving miracle treatment is now a step closer to being allowed in Canada.

The years-long battle to get Trikafta has been an emotional one for patients like Montreal’s Chelsea Gagnon.

“I just started bawling,” Gagnon said of the moment she heard Trikafta had been submitted to Health Canada for approval. “It was just so many emotions at once.”

The 31-year-old from Montreal is one of more than 4,000 Canadians living with CF, a genetic disorder that attacks the respiratory system.

Every year, her condition worsens. Gagnon says she can’t exercise anymore because she coughs up blood every time. There is no cure, though certain drugs like Orkambi have improved quality of life for patients.

None of those drugs has created more optimism than Trikafta, a combination of three drugs created by American pharma company Vertex. A Dalhousie University study recently called it “life-changing,” and acknowledged it can treat 90 per cent of cystic fibrosis patients.

The drug is already available in the U.S. and the U.K., but back in July, Global News reported the company had not even submitted the drug to Health Canada for approval, putting the blame on new government regulations.

This week, that changed.

“After reviewing the final Patented Medicine Prices Review Board (PMPRB) Guidelines, Vertex has made the decision to move forward with our new CF medicines in Canada,” Vertex Pharmaceuticals spokesperson Colin Le Fevre told Global News in a statement.

Trikafta, however, does not yet appear on Health Canada’s list of Submissions Under Review (SUR).

A government spokesperson said Tuesday in a written statement that once a drug submission is filed with Health Canada it will appear on the SUR list.

“At this time, Vertex Pharma has not provided a new drug submission to market Trikafta in Canada,” said Health Canada spokesperson Geoffroy Legault-Thivierge.

But that doesn’t mean the process isn’t in the works.

“Prior to an official filing, Health Canada is not authorized to release information pertaining to a potential submission,” Legault-Thivierge said.

Once a submission is filed, the drug still needs to be approved by Health Canada, but now there’s a glimmer of hope for those like Chelsea.

“I’ve been living with a death sentence over my head for the last 31 years. All of a sudden, you know, I’m given this opportunity to continue living life after 30 years old,” she said.

“We’re just … beside ourselves. It’s just a great day for Canadians living with C.F.,” said Cystic Fibrosis Canada (CF Canada) President and CEO Kelly Grover.

In a press release issued Monday, CF Canada proclaimed the “life-changing” treatment is coming to Canada.

“We heard via clinicians that the manufacturer would be bringing Trikafta to Canada, that an application would be made to Health Canada, and that’s the first step to review the safety and efficacy of the drug. That was a huge hurdle for us,” Grover explained.

Grover said Canada’s health minister has pledged to fast-track the drug through the approval process.

“You know, I can plan to have a family, I can plan to have a career,” said Gagnon. “I can plan to get a house, all these things that have just never, ever crossed my radar because I just had been living my life thinking I’d be dead by 30.”

If the drug is approved by Canada, it will then be up to the individual provinces to decide if it’s covered by Medicare.

Trikafta can cost hundreds of thousands per year without insurance.

Though Gagnon and Grover are both confident the drug will soon arrive, both acknowledge the battle to get it into Canadian hands is not over yet.

Health Canada says that in special circumstances, drugs that are not yet approved in Canada can be accessed through its Special Access Program. As of November 2020, 160 patients have accessed the drug through the program.

— With files from Global News’ Annabelle Olivier

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