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