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House Hansard - 325

44th Parl. 1st Sess.
June 5, 2024 02:00PM
Context: House Hansard - 325 - Jun/5/24
Mr. Scott Reid (Lanark—Frontenac—Kingston, CPC)
  • Jun/5/24 8:08:29 p.m.
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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?
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Context: House Hansard - 325 - Jun/5/24
Mr. Yasir Naqvi (Parliamentary Secretary to the Minister of Health, Lib.)
  • Jun/5/24 8:11:36 p.m.
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Madam Speaker, I want to thank the hon. member for his very thoughtful question. I appreciated the question when he asked it in the House, and I have had an opportunity to speak to him in the hallways about it as well. The question is regarding the urgent need for effective treatments for pulmonary arterial hypertension, or PAH, as he outlined. This serious condition significantly impacts the lives of many Canadians and can impose severe health risks. We are aware of the recent approval of the drug sotatercept by the FDA in the United States, which offers a new option for those affected by PAH. Naturally, the question arises, as the member is asking, when can Canadians expect to be able to access this new medication here in Canada? Our number one priority is the health and safety of Canadians, which includes supporting them in accessing the necessary medications for the health conditions they face. The process for approving new drugs in Canada is thorough and designed to ensure that any therapeutic product made available on the Canadian market meets our high standards for safety, efficacy and quality. While understanding the need for more therapeutic options, we must also ensure that the benefits of any drug outweigh any potential risks. The approval process for a new drug, like this particular drug that we are talking about, involves several key and necessary stages. To market a drug in Canada, manufacturers must first file a submission with sufficient evidence of the product's quality, safety and efficacy. Health Canada reviews the data, which comes from clinical trials, research studies and other sources, to determine whether the product's benefits outweigh its risks. This rigorous evaluation is necessary to ensure that when a new drug, like sotatercept, is approved, it is safe and effective for use by Canadian patients. I can confirm that Health Canada is currently reviewing this specific drug submission under priority review. Priority review is a pathway that supports access to safe, effective and high-quality products. By accelerating the review process, we are committed to ensuring that potentially life-saving treatments reach patients without unnecessary delays. It is important to note that timing for the completion of Health Canada's reviews depends on many factors, including timelines for receiving requested additional data or information, discussions with the sponsors, and the acceptability and completeness of the information submitted. Given these considerations, the timing of when a decision will be made on this submission is not available at this time. However, we expect a decision to be made in the coming months. In conclusion, Health Canada recognizes the important role that sotatercept could play for patients with pulmonary arterial hypertension, which is why it was granted priority review status. A decision will be made once all of the required information has been thoroughly evaluated by Health Canada and upon ensuring that the benefits of this particular drug outweigh the risks of its use. We are committed to a comprehensive review process to ensure that the products Canadians consume are safe and effective.
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