Health Canada Approves Use of Radioiosotope Agent to Diagnose IBD, Detect GI Infection

Health Canada Approves Use of Radioiosotope Agent to Diagnose IBD, Detect GI Infection
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Health Canada has approved use of the nuclear medicine imaging kit Drax Exametazime to help in the diagnosis of inflammatory bowel disease (IBD),

Produced by Jubilant Radiopharma and already approved in the United States, Drax Exametazime is used in nuclear medicine to assist in the location of infections when its source cannot be identified. Such identification is critical to accurate diagnoses and disease characterization, and is a fundamental first step in developing treatment plans.

“We are very pleased that Drax Exametazime is now available to patients in Canada,” Pramod Yadav, CEO of Jubilant Pharma, said in a press release. “This approval aligns with our core strategy of providing our customers with innovative and differentiated nuclear medicine products used for the diagnosis and treatment of diseases.”

Drax Exametazime is a five, single-dose vial kit for preparing technetium (Tc)-99m exametazime for leukocyte (white blood cell) labeling scintigraphy, a nuclear medicine imaging procedure that helps clinicians localize abdominal infection and IBD.

Scintigraphy is a diagnostic test in which radiopharmaceuticals are injected into specific tissues or organs, where emit gamma radiation. Using a gamma camera, physicians can obtain pelvic and abdominal images to assess gut health.

Specifically, a buildup of radioactivity in the bowel with increasing intensity and/or no evidence of gastrointestinal (GI) motility — the natural movement of the digestive system — indicates IBD or infection.

Conversely, radioactivity from hepatic excretion detected in the bowel four hours after an Drax Exametazime injection, and showing change in GI location in subsequent images, indicates normal motility.

“The Health Canada approval further demonstrates the continued commitment by the Jubilant Radiopharma business to advance the field of nuclear medicine, and supports our ongoing mission to improve lives through nuclear medicine,” said Sergio Calvo, president of Jubilant Radiopharmaceuticals division. “We remain committed to providing healthcare professionals with the highest-quality radiopharmaceuticals and dependable advanced technologies designed to enable better patient outcomes across the globe.”

Radiopharmaceuticals are medicinal formulations containing radioisotopes, widely used for diagnosis and therapy.

Some 10 million individuals globally live with inflammatory bowel disease, of which the two most common forms are ulcerative colitis and Crohn’s disease.

Jubilant Radiopharma is the radiopharmceutical division of the pharmaceutical company Jubilant Pharma. Health Canada is the government regulatory agency responsible for that country’s public health programs and policies.

Mary M. Chapman began her professional career at United Press International, running both print and broadcast desks. She then became a Michigan correspondent for what is now Bloomberg BNA, where she mainly covered the automotive industry plus legal, tax and regulatory issues. A member of the Automotive Press Association and one of a relatively small number of women on the car beat, Chapman has discussed the automotive industry multiple times of National Public Radio, and in 2014 was selected as an honorary judge at the prestigious Cobble Beach Concours d’Elegance. She has written for numerous national outlets including Time, People, Al-Jazeera America, Fortune, Daily Beast, MSN.com, Newsweek, The Detroit News and Detroit Free Press. The winner of the Society of Professional Journalists award for outstanding reporting, Chapman has had dozens of articles in The New York Times, including two on the coveted front page. She has completed a manuscript about centenarian car enthusiast Margaret Dunning, titled “Belle of the Concours.”
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Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Técnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.
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Mary M. Chapman began her professional career at United Press International, running both print and broadcast desks. She then became a Michigan correspondent for what is now Bloomberg BNA, where she mainly covered the automotive industry plus legal, tax and regulatory issues. A member of the Automotive Press Association and one of a relatively small number of women on the car beat, Chapman has discussed the automotive industry multiple times of National Public Radio, and in 2014 was selected as an honorary judge at the prestigious Cobble Beach Concours d’Elegance. She has written for numerous national outlets including Time, People, Al-Jazeera America, Fortune, Daily Beast, MSN.com, Newsweek, The Detroit News and Detroit Free Press. The winner of the Society of Professional Journalists award for outstanding reporting, Chapman has had dozens of articles in The New York Times, including two on the coveted front page. She has completed a manuscript about centenarian car enthusiast Margaret Dunning, titled “Belle of the Concours.”
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