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