ACCRUFeR® (ferric maltol) is now available in Canada as a prescription oral treatment for iron deficiency anemia Français
- Iron deficiency is a public health concern with an estimated 6-7% of people living in Canada being iron deficient (ID), and ~2% of the population classified as having iron deficiency anemia (IDA)1.
- Symptoms of ID/IDA can be debilitating and significantly impact health outcomes, work productivity and quality of life in adults2,3.
- ACCRUFeR® is the only oral iron therapy approved as a prescription drug in Canada.
MISSISSAUGA, ON, March 11, 2025 /CNW/ - Kye Pharmaceuticals, Inc. ("Kye") announced today that ACCRUFeR® (ferric maltol) is now available across Canada. ACCRUFeR® is approved as a prescription medicine in Canada for adults with iron deficiency anemia (IDA) who are unresponsive or intolerant to other oral iron preparations4. ACCRUFeR® is currently the sole prescription-only oral treatment option indicated for IDA in Canada.
"The availability of ACCRUFeR® across Canada provides patients and physicians with a valuable treatment option between over-the-counter iron supplements and more invasive intravenous iron preparations," said Julian Oliver, Commercial Lead General Medicines and Business Operations, Kye Pharmaceuticals. "We are proud to bring an evidence-based oral iron-therapy to Canada that has demonstrated long-term efficacy and safety in both placebo-controlled and active comparator clinical trials."
Kye Pharmaceuticals supports efforts across Canada to raise awareness, screening, and treatment of ID and IDA. Kye commends the efforts of physician and patient groups who advocate for early detection, promote education on the impact of iron deficiency, and work to improve access to effective care for those affected.
"The introduction of a Health Canada approved prescription oral iron therapy, with an innovative delivery system represents a major advancement for Canadian patients managing IDA," said Dr. Karima Khamisa, Consultant Hematologist. "This novel therapy provides physicians a prescription treatment option which patients can administer at home."
ACCRUFeR® is a novel, stable, non-salt-based, non-polysaccharide oral therapy composed of stable ferric (Fe3+) iron complexed with a naturally occurring sugar derivative, maltol. Unlike traditional oral iron supplements containing ferrous (Fe2+) iron, Fe3+ has been shown to have improved tolerability5. The maltol complex protects the iron as it passes through the stomach minimizing gastrointestinal side effects.6
"As a physician with a clinical focus on women's health, I am deeply aware of the challenges faced by patients with IDA," said Dr. Christine Palmay, MD, CCFP, FCFP, Family Physician. "Access to a new evidence-based therapy to treat IDA is a welcome addition to our therapeutic toolkit that could potentially improve convenience and adherence for patients. What may seem like a simple fix can result in drastic improvements in a patient's quality of life."
Effective March 11, 2025, ACCRUFeR® is available by prescription through pharmacies across Canada.
About Iron Deficiency and Iron Deficiency Anemia
Clinically low iron levels (iron deficiency, ID) and associated anemia (IDA) can cause serious health problems for adults of all ages, with or without underlying disease conditions3. The Canadian Health Measures Survey (CHMS) estimates that 6.1% of the total Canadian population have ID, with females being more disproportionately affected (8.3%) versus males (4%)1.
About ACCRUFeR®
As the only Health Canada approved prescription oral iron to treat ID/IDA, ACCRUFeR® has the potential to address an important unmet medical need for both physicians and patients. Gastrointestinal side effects present a major challenge in adhering to traditional salt-based oral iron supplements7. In clinical trials, Accrufer® has been shown to correct IDA by normalizing serum iron markers and was well tolerated in diverse patient populations6,8. More information about ACCRUFeR®, can be found at: www.kyepharma.com.
About Shield Therapeutics plc
Shield is a commercial-stage specialty pharmaceutical company that delivers ACCRUFeR® (ferric maltol), an innovative and differentiated pharmaceutical product, to address a significant unmet need for patients suffering from iron deficiency, with or without anaemia. The Company has launched ACCRUFeR® in the U.S. with an exclusive, multi-year commercial agreement with Viatris Inc. (Viatris). Outside of the U.S., the Company has licensed the rights to four specialty pharmaceutical companies. Feraccru® is commercialised in the UK and European Union by Norgine B.V. (Norgine), which also has marketing rights in Australia and New Zealand. Shield also has an exclusive license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd. for the development and commercialization of ACCRUFeR®/ Feraccru® in China, Hong Kong, Macau and Taiwan; with Korea Pharma Co., Ltd. for the Republic of Korea (Korea Pharma); and with Kye Pharmaceuticals Inc. for Canada. To learn more about Shield Therapeutics, see our website at www.shieldtherapeutics.com. ACCRUFeR®/Feraccru® are registered trademarks of Shield Therapeutics.
About Kye Pharmaceuticals Inc.
Kye is a growth-stage Canadian specialty pharmaceutical company, headquartered in Toronto, committed to bringing value to Canadians by identifying, licensing, and commercializing novel prescription medicines that are not otherwise available to patients across Canada. With a growing pipeline of innovative medicines, Kye's portfolio spans a range of therapeutic areas including neurology, psychiatry, pediatrics, rare diseases, hematology, cardiology and neuromuscular disorders. Kye is focused on licensing and launching medicines that matter, and delivering better outcomes to our partners, Canadian healthcare professionals, and most importantly, patients across Canada. For more information please visit www.kyepharma.com.
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- Camaschella C. N Engl J Med. 2015;372(19) :1832-43
- https://www.who.int/health-topics/anaemia#tab=tab_2 (accessed Jan 2025)
- ACCRUFeR® (ferric maltol) oral capsules. Product Monograph. Kye Pharmaceuticals Inc., Mississauga, ON.
- Khoury A, et al. Ann Pharmacother. 2021;55(2):222-229
- Gasche C, et al. Inflamm Bowel Dis. 2015;21(3) :579‐588
- olkien Z, et al. Plos One. 2015;10(2):e0117383
- Pergola PE, et al. Am J Kidney Dis. 2021:S0272-6386(21)00624-7
SOURCE Kye Pharmaceuticals Inc.
For further information please contact: Kye Pharmaceuticals Inc., www.kyepharma.com; John McKendry, President & CEO, [email protected], 1-888-822-7126; Denise David, Vice-President Scientific Affairs, [email protected], 1-888-822-7126
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