Photo Credit: Pharmascience Inc.

Health Canada Approves MYINFLA, a New Repurposed Treatment for Cardiovascular Disease

Tuesday, August 31, 2021 8:00:00 AM

- A unique partnership between Pharmascience and the Montreal Heart Institute (MHI) leads to the approval of MYINFLA TM (colchicine 0.5 mg extended-release tablets), a known drug repurposed as a new treatment option for the reduction of cardiovascular risks in patients with coronary artery disease. -

Pendopharm, a division of Pharmascience Inc., is pleased to announce that Health Canada has issued a Notice of Compliance (NOC) approving MYINFLA TM (colchicine 0.5 mg extended-release tablets), a prescription medicine for use in the reduction of cardiovascular risks in patients with coronary artery disease. Pharmascience wishes to thank Health Canada for its priority review of the file in the difficult context of COVID-19.

In Canada, heart disease is the second leading cause of death and continues to be a leading cause of hospitalization1. While prevention and education remain effective ways to help reduce the toll of this disease on Canadians, developing additional, evidence-based, and cost-effective treatment options is critical. MYINFLA TM will now add to those options to address this major public health issue.

MYINFLA TM: A Successful Partnership Between the Montreal Heart Institute and Pharmascience

Health Canada's approval of MYINFLATM was primarily based on the results of the Colchicine Cardiovascular Outcomes Trial (COLCOT) led by Dr. Jean-Claude Tardif from the MHI, in partnership with Pharmascience. As seen in COLCOT, MYINFLATM significantly reduced the risk of a first ischemic cardiovascular event and the risk of total ischemic cardiovascular events by 23% and 34%, respectively, in addition to standard of care in patients with a recent myocardial infarction (MI). The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization. These results were published in the prestigious New England Journal of Medicine (Tardif et al., N Engl J Med 2019; 381:2497-505).

"I am pleased by the approval of MYINFLA TM by Health Canada based on the COLCOT trial. The success and availability of MYINFLA TM proves the value of investigating known therapeutic agents to find new treatment options to improve patient outcomes and expanding the possibilities for life science innovation," said Dr. Jean-Claude Tardif.

MYINFLA TM is indicated for the reduction of atherothrombotic events in adult patients with existing coronary artery disease, in addition to standard therapies, including LDL-C (low-density lipoprotein cholesterol) lowering and antithrombotic drug treatment. It is formulated in a novel, lower-dose, extended-release tablet.

A Case for Repurposing

"Thanks to the partnership that we developed with MHI in the COLCOT study, Dr. Tardif and his team were able to generate concrete results that highlight the benefits of colchicine repurposing. This paves the way for a faster, more cost-effective approach to bring new therapies to patients, by taking advantage of the known safety profile of the drug," said David Goodman, Ph.D., President and CEO of Pharmascience.

The active ingredient in MYINFLA TM, colchicine, has been used for decades as a treatment for gout with recognized anti-inflammatory properties. Today's approval of MYINFLA TM marks a significant milestone for the Canadian healthcare system, as it demonstrates the additional benefits that can be derived from an established drug when repurposed into new indications.

SOURCE: Pharmascience Inc.