Nippon Shinyaku : Launch of VyxeosⓇ Combination for I.V. Injection for the Treatment of High-risk AML in Japan

NEWS RELEASE

May 22, 2024

Launch of Vyxeos® Combination for I.V. Injection for the Treatment of

High-risk AML in Japan

Kyoto, Japan, May 22, 2024 - Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; Headquarters, Kyoto; President, Toru Nakai) announced today that it has launched Vyxeos® Combination for I.V. Injection (Daunorubicin hydrochloride/cytarabine liposomal drug for injection) for the treatment of high-risk acute myeloid leukemia (AML) in Japan. This follows the marketing approval of Vyxeos®, which was granted by the Ministry of Health, Labour and Welfare (MHLW) on March 26, 2024.

AML is a disease of clonal proliferation of immature myeloid cells, and results from genetic abnormalities in myeloblasts which are immature blood cells. The uncontrollable growth of leukemia cells in the bone marrow prevents the production of normal blood which results in various symptoms such as infections and bleeding.1 Although multiple AML drugs have been launched in recent years and the outcomes for some patient groups have improved, many patients still do not have long- term survival. Novel therapeutic agents with greater efficacy are needed.2

Vyxeos® is a liposomal formulation of a fixed combination of cytarabine and daunorubicin, the standard drugs for AML treatment, at 5:1 molar ratio. The 5:1 molar ratio has been shown to maximize synergistic antitumor activity in AML. After the drug is taken up by leukemia cells in the bone marrow, cytarabine and daunorubicin are released to exert its anti-tumor effect.

Nippon Shinyaku acquired a license for Vyxeos® from Jazz Pharmaceuticals plc (Headquarters: Dublin, Ireland, Chairman and CEO: Bruce C. Cozadd) on March 30, 2017. Vyxeos® is approved for the treatment of therapy-related AML and AML with myelodysplastic changes in more than 31 countries or regions around the world, including Europe and the United States.

Nippon Shinyaku believes that it will contribute to the treatment of high-risk AML* by delivering Vyxeos® appropriately to healthcare professionals and their patients who need it.

• The definition of high-risk AML is if any of the following conditions below apply. ・therapy-related AML
  ・AML with a history of myelodysplastic syndromes (MDS) ・de novo AML with MDS-related cytogenetic abnormalities
  ・AML with a history of chronic myelomonocytic leukemia (CMML)

References

1. Japanese Society of Hematology. Practical Guidelines for Hematological Malignancies, 2023, Kanehara & Co., Ltd. (Japanese only).
2. Gurnari C et al. Deciphering the Therapeutic Resistance in Acute Myeloid Leukemia. Int J Mol Sci. 2020; 21(22):8505.

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Summary of Vyxeos®

Brand name	Vyxeos® Combination for I.V. Injection
Generic name	Daunorubicin hydrochloride/cytarabine liposomal drug for injection
Date of approval	March 26, 2024
Date of NHI reimbursement	May 22, 2024
price listing
Date of launch	May 22, 2024
Number of approval	30600AMX00112000
Dosage Forms and Strengths	Freeze-dried preparation for injection containing 47mg of daunorubicin
hydrochloride (44mg as daunorubicin) and 100mg of cytarabine in 1 vial
Indication	High-risk acute myeloid leukemia
	(1) Remission induction therapy
	Usually, as remission induction therapy, 100 units (44mg as
	daunorubicin and 100mg as cytarabine)/m2 (body surface area) of
	Vyxeos® Combination for I.V. Injection shall be administered over 90
	minutes once daily for up to two cycles.
	This drug shall be intravenously administered by drip infusion on Days
	1, 3, and 5 of Cycle 1. This drug shall be intravenously administered by
	drip infusion on Days 1 and 3 of Cycle 2 to patients who do not achieve
	remission during Cycle 1, if there are no unacceptable toxicities, two to
	five weeks after the start of Cycle 1.
	(2) Consolidation therapy
Dosage and Administration	Usually, as consolidation therapy, 65 units (29mg as daunorubicin and
65mg as cytarabine)/m2 (body surface area) of Vyxeos® Combination for
	I.V. Injection shall be administered over 90 minutes once daily for up to
	two cycles.
	This drug shall be intravenously administered by drip infusion on Days
	1 and 3 of Cycle 1, five to eight weeks after the start of the last remission
	induction therapy. This drug shall be intravenously administered by drip
	infusion on Days 1 and 3 of Cycle 2 to patients without disease
	progression after the start of administration of Cycle 1, if there are no
	unacceptable toxicities, five to eight weeks after the start of Cycle 1 of
	the consolidation therapy.
	One dose unit of this drug contains 0.44mg of daunorubicin and 1mg of
	cytarabine.
NHI reimbursement price	JPY 877,877/vial
Packaging unit	1 vial

About Nippon Shinyaku

Based on Nippon Shinyaku's business philosophy, "Helping people lead healthier, happier lives," we aim to be an organization trusted by the community through creating unique medicines that will bring hope to patients and families suffering from illness. Please visit our website (https://www.nippon-shinyaku.co.jp/english/) for products or detailed information.

Contact

Corporate Communications Dept., Nippon Shinyaku Co., Ltd.

FAX: [phone]

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