Jazz Pharmaceuticals Submits Vyxeos™ Marketing Authorization Application to European Medicines Agency for Treatment of Certain Types of High-Risk Acute Myeloid Leukemia
The CHMP granted Vyxeos accelerated assessment, which is designed to reduce the review timeline for products of major interest for public health and therapeutic innovation. Vyxeos also received Promising Innovative Medicine (PIM) designation from the
"If approved, Vyxeos will become the first new chemotherapy treatment option specifically for European patients with therapy-related AML or AML with myelodysplasia-related changes," said
The MAA for Vyxeos includes clinical data from five studies, including the pivotal Phase 3 study. Data from the Phase 3 study, which demonstrated a statistically significant improvement in overall survival for Vyxeos versus standard of care, were presented at the
"Despite numerous advances in the treatment of cancer in
Vyxeos daunorubicin 2.2 mg/mL and cytarabine 5 mg/mL powder for concentrate for infusion is an advanced liposomal formulation that delivers a fixed-ratio (1:5) of daunorubicin and cytarabine to the bone marrow that has been shown to have synergistic effects at killing leukemia cells in vitro and in animal models. Vyxeos is the first product developed with the company's proprietary CombiPlex® platform, which enables the design and rapid evaluation of various combinations of therapies. Vyxeos received Orphan Drug Designation by the
Acute myeloid leukemia (AML) is a blood cancer that begins in the bone marrow, which produces most of the body's new blood cells.1 AML cells crowd out healthy cells and move aggressively into the bloodstream to spread cancer to other parts of the body.2 The median age at diagnosis is 68 years old, with rising age associated with a progressively worsening prognosis.3-4 There is also a reduced tolerance for intensive chemotherapy as patients age.5 Patients with t-AML or AML-MRC have few treatment options and some of the lowest survival rates compared to people with other forms of leukemia.6-7 A hematopoietic stem cell transplant (HSCT) may be a curative treatment option for patients.8
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to Vyxeos as a treatment option for European patients with t-AML or AML-MRC, the expected impact of accelerated assessment review status on the Vyxeos MAA, and other statements that are not historical facts. These forward-looking statements are based on the company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: the regulatory approval process, including the company's ability to maintain accelerated assessment review status for the Vyxeos MAA or obtain approval for Vyxeos in the EU in a timely manner or at all; and the manufacture and effective commercialization of Vyxeos in the EU; and other risks and uncertainties affecting the company and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in
3. SEER Stat Facts: AML. 2017.
4. Baer MR, et al., Leukemia, 2011 May; 25(5):10.1038/eu.2011.9.
5. Klepin HD. Hematology Am Soc Hematol Educ Program. 2014 (1):8-13.
6. Pinto AC, et al. Current
7. Smith SM, et al. Blood. 2003; 102(1):43-52.
8. Peccatori, J and Ciceri, F. Haematologica. 2010 Jun; 95(6): 857–859. doi: 10.3324/haematol.2010.023184.
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Media: Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations, Ireland +353 1 697 2141, U.S. +1 215 867 4910; or Investor: Kathee Littrell, Vice President, Investor Relations, Ireland +353 1 634 7887, U.S. +1 650 496 2717