Kye Pharmaceuticals has recently informed the Sjögren’s Society of Canada (SjSC) that they have been unsuccessful in their appeal to overturn Health Canada’s non-approval of cevimeline/Sholyne for use in Canada. Since 2019, with the assistance of the SjSC, Kye submitted a New Drug Submission and several appeals for reconsideration. Health Canada’s response stated that “insufficient information has been provided to support the safety and efficacy of your product”. Unfortunately, Kye Pharmaceuticals no longer sees a path forward for having cevimeline approved in Canada.

Cevimeline/Evoxac is 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 since then 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. Cevimeline is no longer available through the SAP program.

In their September 2022 response to Kye’s appeal, Health Canada focused on the insufficiencies of the original clinical trials completed over two decades ago while also stating that the FDA “post-market adverse events reports have little utility as a source of efficacy data”.

The SjSC Board of Directors is disappointed in Health Canada’s decision. Sjögren’s patients in Canada should have access to more than one salivary stimulating medication, (pilocarpine/Salagen), one that may be more effective in reducing the effects of xerostomia. Thank you to our members who participated in our campaign to protest Health Canada’s characterization (in an April 2022 Notice of Non-Compliance) of Sjögren’s as a “non-serious” condition. Health Canada later apologized for their poor choice of words.  Unfortunately, our campaign was unsuccessful in affecting the final decision.

The only option available for Sjögren’s patients to access cevimeline Is by travelling to the U.S. to meet with a physician and purchasing the drug at a U.S. pharmacy.

Mary McNeil, SjSC Board of Directors

Language Matters: Results from the Nomenclature Survey

In mid-July, members of the Sjögren’s Society of Canada (SjSC) received a request to complete a short survey pertaining to the nomenclature of their disease. The request arose out of a European-North American initiative formed to address the name of the disease, currently known internationally as “Sjögren’s Syndrome”. A Steering Committee had been struck which will address both the nomenclature used for the disease name as well as the classification of the disease at the 15th International Symposium on Sjögren’s Syndrome (ISSS) being held September 7-10, 2022, in Rome, Italy.

As a member of that Steering Committee, I had been asked what the Canadian perspective was but did not feel I could answer on your behalf without asking you. As a result, a short survey was formed. We were given a very short lead time to submit our answers, but nevertheless, we had a total of 187 respondents. The results of the 3-question survey are as follows:

1)     Do you prefer to retain “Sjögren” or “Sjögren’s” in the name of the disease?

Retain “Sjögren” or “Sjögren’s” as part of the disease name.         60.00%

Discard “Sjögren” or “Sjögren’s” as part of the disease name.       35.00%

Don’t know/ prefer not to provide an opinion.                                   5.00%

2)     If the name of “Sjögren” or “Sjögren’s” is retained, which of the following terms do you prefer to accompany Sjögren or Sjögren’s?

Sjögren/Sjögren’s with no other terminology                                     10.00%

Sjögren/Sjögren’s Syndrome                                                               2.50%

Sjögren/Sjögren’s Disease                                                                 40.00%

Sjögren/Sjögren’s followed by scientific/medical terminology            42.50%

Don’t know/ prefer not to provide an opinion                                        5.00%

3)     Do you agree or disagree with eliminating the terms “primary” and “secondary” with respect to the disease?

Agree with eliminating these terms                                                       97.44%

 Disagree with eliminating these terms                                                  2.56%

I would like to extend my thanks to all who participated and am extremely appreciative that so many of you answered in such a short period of time.

Leslie P. Laing

The SjSC would like to thank everyone who took the time to send a letter to Dr. J. Patrick Stewart, from the Therapeutic Products Directorate at Health Canada to protest the non-approval of cevimeline/Sholyne.  Many of you also added some very impactful comments about your personal experiences with dry mouth and Sjögren’s. We also heard from several physicians and dentists who participated in the protest.

We appreciate that Health Canada is replying to every person who sent them a letter with their rationale for non-approval and suggestions for alternative next steps. In their response to our concern about describing Sjögren’s as “non-serious” they stated: “We sincerely regret the misinterpretation this choice of wording has led to and will ensure we improve the message….in any future report or communication on Sholyne”. 

Kye Pharmaceuticals is in the process of appealing Health Canada’s non-approval of cevimeline/Sholyne.  Their “Request for Reconsideration” will be submitted June 20th. We are optimistic that our protest campaign has provided Health Canada with a different perspective to evaluate the appeal. Stay tuned for further updates.

If you still wish to participate in the protest, the details and the letter are posted on our website www.sjogrenscanada.org under “Living with Sjögren’s/Blog”. 

Sjögren’s Society of Canada Board of Directors

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:

john.patrick.stewart@hc-sc.gc.ca

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 (info@sjogrenscanada.org) or by calling 1-888-558-0950.

Thank you for your help!

Dr. J. Patrick Stewart MD, CCFP(EM)

Director General

Therapeutic Products Directorate

Health Canada

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,

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