We need your help to protest a recent decision by Health Canada not to approve cevimeline for use in Canada.
You may have heard of cevimeline/Evoxac, a medication commonly used by Sjögren’s patients in the U.S. to relieve the symptoms of dry mouth by increasing salivary flow. It was approved 22 years ago by the Food and Drug Administration (FDA) with no new signals suggesting efficacy or serious safety concerns. Beginning in late 2019, Health Canada and Kye Pharmaceuticals made cevimeline available through the Special Access Programme (SAP) with every expectation there was an imminent approval forthcoming. Over 20 members expressed interest in the SAP.
Pilocarpine is the only medication currently available in Canada that treats dry mouth, but it does not work for many Sjögren’s patients and is often poorly tolerated with significant side effects. Why would patients in Canada not have access to a second medication to treat dry mouth?
Kye Pharmaceuticals began the process of applying for approval in January 2020 under the brand name, SHOLYNE™. Health Canada focused on the original clinical trials conducted 22 years ago and ignored the 20 years of safety and efficacy records in the U.S. They also described Sjögren’s as a “non-serious” disease in their decision letter to Kye which we all know is far from the truth.
This is how you can help. Please review and e-mail this letter and sign it by typing your name at the end of the letter. Then e-mail the letter to Dr. J. Patrick Stewart, the Director General of the Therapeutic Products Directorate of Health Canada:
Please forward the letter as soon as possible. If you prefer to mail it, Dr. Stewart’s address is on the letter. Consider copying your federal MP whose email address may be found at https://www.ourcommons.ca/members/en/search
If you have questions, contact the SjSC by e-mail (firstname.lastname@example.org) or by calling 1-888-558-0950.
Thank you for your help!
Dr. J. Patrick Stewart MD, CCFP(EM)
Therapeutic Products Directorate
Holland Cross, Tower “B”
6th Floor, 1600 Scott Street
Address Locator # 3106B
Ottawa, Ontario K1A 0K9
Dear Dr. Stewart:
As a member of the Sjögren’s Society of Canada (SjSC), I am writing to protest Health Canada’s decision to deny approval of the Sholyne™ (cevimeline hydrochloride) New Drug Submission Control No. 240337 by Kye Pharmaceuticals.
I and fellow SjSC members were disheartened to read in the decision letter which Kye shared with the SjSC, that Health Canada describes our disease as “non-serious” in their benefit-risk profile for Sholyne™. Sjögren’s is not only serious and life-threatening, but it is also a chronic, systemic, inflammatory autoimmune disease which affects an estimated 1% of Canadians, 90% of whom are women. While often considered to be “an invisible” disease since we “look normal,” the manifestations of Sjögren’s have a profound negative and debilitating effect on our quality of life. Although dry eyes, dry mouth, joint pain, and excessive fatigue are the hallmark symptoms, there are over sixty other serious systemic complications affecting all organs leading to such serious conditions as lymphoma and lung disease.
Consider one of our members who finds that with the special access to use of cevimeline she is now able to do her job effectively as a lawyer whereas without its use, her mouth is too dry to allow her to speak clearly. In fact, up to 98% of Sjögren’s patients suffer from dry mouth due to reduced salivary gland function. This leads not only to a decrease in available saliva, but also to the potential of oral ulcers, cracked tongue, and swollen and infected glands. It is not just a comfort issue, since saliva is necessary for speaking, eating, chewing, swallowing, and digesting. Furthermore, one of the worst ravages of a dry mouth is dental decay. Try as we may, it is a losing battle trying to keep ahead of the rampant oral decay. The annual costs of dental treatment for Sjögren’s patients can be astronomical and appear to be never-ending due to frequent failure of common routine dental restorations.
Some of our members have been fortunate enough to have been granted access to cevimeline since the fall of 2019 through Health Canada’s Special Access Programme (SAP). Cevimeline was approved for use by the American Food and Drug Administration over twenty years ago, with no trends emerging that signal a lack of efficacy or serious safety issues. It was highly anticipated that through the diligence of Kye Pharmaceuticals the distribution of Sholyne™ (cevimeline hydrochloride) would be approved by Health Canada. This would eliminate the need for rather costly and dubious cross-border referrals to American providers and drug stores to access the medication.
Although there is a medication currently available in Canada that attempts to address the issue of dry mouth, that of pilocarpine, it has been shown to have significant side effects and is often poorly tolerated by Sjögren’s patients who have taken it. Cevimeline would finally provide us with a second medication that is more effective, longer lasting, better tolerated, and has been used for decades by our fellow American patients.
In conclusion, we protest Health Canada’s decision not to approve Sholyne™ and strongly request that you reconsider your decision and finally allow Sjögren’s patients in Canada access to a proven drug that addresses the serious complications of dry mouth.
Thanking you in advance for your consideration,