DUBLIN,?July 7, 2021?/CNW/ -?Jazz Pharmaceuticals plc?(NASDAQ: JAZZ) today announced the?Health Canada?approval and availability of Vyxeos^??(daunorubicin and cytarabine liposome for injection) for the treatment of adults with newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).¹ AML, a cancer of the bone marrow and the blood, progresses rapidly without treatment.^2?Specifically, high-risk AML includes t-AML and AML-MRC.³?T-AML is caused by previous therapeutic treatments while AML-MRC occurs when there are certain changes in the bone marrow, which is the spongy tissue inside the bones.¹ Considered a rare disease, AML affects approximately 1,100 men and women in?Canada?annually.⁴? Though the number of AML cases has continued to rise⁵, the current treatment regimen for patients with high-risk AML has remained the same for decades until now.^6? "Vyxeos?is not only an effective treatment option but a significant advance by providing this patient population with a chemotherapy agent that takes less time to administer and provides a better chance at survival than our standard current treatment for high-risk AML," said Dr.?Brian Leber, clinical hematologist,?Juravinski Cancer Centre,?Hamilton Health Sciences?in Hamilton, Ontario.?"Having more time is a substantial win for these patients and their families." The approval of?Vyxeos?is based on results from a Phase 3 study of 309 adult?patients, aged 60-75, with newly diagnosed t-AML or AML-MRC.¹?The study met its primary endpoint as?Vyxeos?demonstrated a superior improvement in overall survival compared to the current conventional treatment group.¹?The median overall survival for the?Vyxeos?treatment group was 9.6 months compared with 6.0 months for the current conventional treatment?group.¹ The most common adverse reactions (= 10% Incidence) attributed to?Vyxeos?are infection, febrile neutropenia, rash, transfusion reactions, sleep disorders, anxiety, delirium, headache, dizziness, visual impairment, non-conduction cardiotoxicity, arrhythmia, chest pain, hemorrhage, hypotension, hypertension, dyspnea, cough, pleural effusion, hypoxia, nausea, diarrhea/ colitis, mucositis, constipation, abdominal pain, decreased appetite, vomiting, hemorrhoids, pruritus, petechiae, musculoskeletal pain, renal insufficiency, edema, fatigue, chills, pyrexia and catheter/device/ injection site reaction.¹ "As a company dedicated to bringing life-changing medicines to market and redefining possibilities, the approval of?Vyxeos?in?Canada?represents Jazz's promise of putting patients first," said?Paul Petrelli, general manager,?Jazz Pharmaceuticals Canada Inc.?"Vyxeos?is an important example of how we meet the needs of the hematology and the oncology communities by offering a treatment that may extend life for high-risk AML patients." Vyxeos?is part of a group of medicines called "antineoplastics" used against cancer.¹?It contains two medicinal ingredients, daunorubicin and cytarabine,¹?which are packaged in tiny particles known as liposomes.¹?Vyxeos?is believed to kill cancer cells by stopping them from growing and dividing.¹?Packaging the medicinal ingredients in liposomes allows the drug to stay longer in the body.¹?The liposomes packaging also helps the drug enter the body and kill the cancer cells.¹ About?Vyxeos Vyxeos?(daunorubicin and cytarabine liposome for injection) is a chemotherapy treatment option specifically indicated for the treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).¹ Vyxeos?is administered by intravenous infusion over a period of 90 minutes.¹ Vyxeos?liposomes accumulate and persist in the bone marrow where they are taken up intact by?leukemia?cells to a greater extent than by non-leukemic?bone marrow cells?based on in-vivo animal studies.⁷ It is the first product to be developed with?Jazz Pharmaceuticals'?CombiPlex^??technology platform, which uniquely enables the design, rapid evaluation and delivery of various combinations of therapies.⁸ Important Safety Information for?Canada¹ Vyxeos should not be given to patients who are:

• allergic to daunorubicin or cytarabine, or to any of the other ingredients of this drug.

Vyxeos must be prescribed and administered to patients by specialized physicians experienced in the use of chemotherapeutic medicinal products." The most common side effects of?Vyxeos?are infection, febrile neutropenia, rash, transfusion reactions, sleep disorders, anxiety, delirium, headache, dizziness, visual impairment, non-conduction cardiotoxicity, arrhythmia, chest pain, hemorrhage, hypotension, hypertension, dyspnea, cough, pleural effusion, hypoxia, nausea, diarrhea/ colitis, mucositis, constipation, abdominal pain, decreased appetite, vomiting, hemorrhoids, pruritus, petechiae, musculoskeletal pain, renal insufficiency, edema, fatigue, chills, pyrexia and catheter/device/ injection site reaction.¹ Vyxeos?has different dosing directions than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection and cytarabine liposome injection. Your healthcare professional will make sure you are getting the right drug and dose before giving you?Vyxeos. If you think you may have received a different drug than usual, talk with your healthcare professional. For more information, please refer to the product monograph for?Vyxeos?in?Canada?located?here. About AML² AML is a rare type of blood cancer that begins in the bone marrow and blood. It damages the DNA?(genetic material) of a developing stem cell in the bone?marrow. This is called an "acquired?mutation." Stem cells?form?blood cells?(red cells, white cells and?platelets). This damaged cell becomes a leukemic cell and multiplies into billions of cells called leukemic blasts that block the production of normal cells. As a result, the number of healthy blood cells (red cells, white cells and platelets) is usually lower than normal and are crowded out by cancer or leukemic cells.?The median age at diagnosis is 67. Symptoms may include but are not limited to pale skin, bruises with no clear cause and an enlarged liver or spleen. There is no known cause for most cases of AML. About?Jazz Pharmaceuticals plc Jazz Pharmaceuticals plc?(NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases?often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in?Dublin, Ireland?and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit?www.jazzpharmaceuticals.com?and follow @JazzPharma on Twitter. References   SOURCE?Jazz Pharmaceuticals Canada Inc