Madam Speaker, on May 24, I raised the following question, which I will repeat verbatim for the purpose of context:
...pulmonary arterial hypertension, also known as PAH, is a disease that blocks arteries in the lungs, causing high blood pressure in the lungs and damaging heart tissue. Patients diagnosed with PAH have, on average, three years to live.
In the [U.S.], a drug called sotatercept was recently approved by the FDA. This drug increases quality of life and lifespan for PAH patients and even...reverses the damage caused by the disease.
When will this life-saving drug be approved for use in Canada?
At that time, the Parliamentary Secretary to the Minister of Health promised to get back to the House at a later date with a detailed answer. I am hoping he will be able to do so today. Here are some of the details that I think might be relevant to the discussion.
In the United States, the FDA, the Food and Drug Administration, holds the power to determine whether new drugs will be permitted. To be approved, a drug must complete three trial phases that, collectively, determine whether the drug is both safe and efficacious. Phase 3 trials on sotatercept were completed in 2023 and were published in a peer-reviewed journal in September, 2023.
The published results were impressive, including the observation that the drug “significantly improved multiple important secondary outcome measures, including reducing the risk of death from any cause or PAH clinical worsening events by 84% versus background therapy alone”. FDA approval for therapeutic use of sotatercept was granted on March 26.
These promising results are probably the reason why, in March, Health Canada assigned sotatercept to its priority review policy, a policy within Health Canada designed to allow for the more rapid approval of efficacious therapies for life-threatening conditions. According to section 1.5 of Health Canada's guidance document relating to the program, “The performance target for the screening and review of the original submission is 215 calendar days (10 days processing within the Submission and Information Policy Division, 25 days screening with the Submission Management Division of the appropriate Directorate, 180 days submission review)”. It is a total of 215 days.
Of course, the review could produce a negative result. However, in the event that the review described above is positive and that Health Canada is satisfied that the published clinical results cited above are valid, would it be safe to assume that sotatercept will become an approved therapy for Canadian PAH sufferers within 215 days of the end of March, that is to say by the end of November of this year?