Market Overview

Shionogi Announces U.S. Availability of Mulpleta® (Lusutrombopag) for the Treatment of Thrombocytopenia in Adults with Chronic Liver Disease Scheduled to Undergo a Procedure

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Shionogi & Co., Ltd. (hereafter "Shionogi") announced today that Mulpleta®
(lusutrombopag), a once-daily, orally administered, small molecule
thrombopoietin (TPO) receptor agonist for the treatment of
thrombocytopenia in adult patients with chronic liver disease (CLD) who
are scheduled to undergo a procedure, is now available throughout the
United States.

"We are very excited about the launch of Mulpleta in the United States,
recently approved as a new, safe and effective treatment," said Takayuki
Yoshioka, President and Chief Executive Officer, Shionogi Inc. "As adult
patients with CLD often undergo procedures that could put them at
increased risk for bleeding, this treatment will offer physicians and
patients an option other than platelet transfusions. Additionally, we
have developed Mulpleta Assist, a support center for physicians
and patients, to help make Mulpleta easier to access and ensure that
patients receive Mulpleta before their procedure."

Mulpleta Assist is a full-service patient access and support
program that offers healthcare providers and patients a dedicated
resource to help manage medication logistics, coordinate managed care
reimbursement, match financial assistance, as well as provide overall
patient support. Shionogi is committed to helping patients access and
afford Mulpleta and have the support necessary to achieve the full
benefit of this therapy. To learn more about Mulpleta or Mulpleta
Assist
, please visit www.Mulpleta.com.

The United States Food and Drug Administration (FDA) approved Mulpleta
on July 31, 2018. The FDA approval was based on consistent safety and
efficacy data from two Phase 3 clinical trials, L-PLUS 1 and L-PLUS 2,
in which Mulpleta met primary and secondary endpoints with statistically
significant results.

About Thrombocytopenia in Chronic Liver Disease

Thrombocytopenia is a common complication of CLD, which may be caused by
multiple factors including decreased production of TPO. Thrombocytopenia
is frequently observed in patients with CLD, with studies suggesting
that it occurs in up to 78% of patients with cirrhosis.1 CLD-associated
thrombocytopenia is defined as a platelet count of less than 150,000/µL
and is the most common hematologic complication of CLD.2,3,4 Patients
with CLD and thrombocytopenia are at increased risk for bleeding,
requiring recurrent platelet transfusions, increased ambulatory visits
and inpatient hospital stays compared with patients with CLD without
thrombocytopenia.5 The annual health care cost of a patient
with CLD with thrombocytopenia is more than three times that of a
patient with CLD without thrombocytopenia.5 In addition to
the potential of thrombocytopenia, especially severe thrombocytopenia
(platelet count less than 50,000/µL), to aggravate surgical or traumatic
bleeding, it may also significantly complicate routine diagnostic
procedures and patient care, such as liver biopsy and medically
indicated or elective procedures for cirrhotic patients, resulting in
delayed or cancelled curative treatment.6

About Mulpleta

Mulpleta (lusutrombopag) is a once-daily, orally administered, small
molecule TPO receptor agonist for the treatment of thrombocytopenia in
adult patients with CLD who are scheduled to undergo a procedure.
Mulpleta is an orally bioavailable, small molecule TPO receptor agonist
that interacts with the transmembrane domain of human TPO receptors
expressed on megakaryocytes to induce the proliferation and
differentiation of megakaryocytic progenitor cells from hematopoietic
stem cells and megakaryocyte maturation.

Mulpleta was approved by the Ministry of Health, Labor and Welfare in
Japan in September 2015 for the improvement of thrombocytopenia
associated with CLD in patients undergoing an elective invasive
procedure. The European Medicines Agency has validated for review
Shionogi's standard Marketing Authorization Application for
lusutrombopag and approval is expected in 1H 2019.

Please see Important Safety Information, including Warnings &
Precautions and Adverse Reactions below
.

INDICATION

Mulpleta® (lusutrombopag) is indicated for the
treatment of thrombocytopenia in adult patients with chronic liver
disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Mulpleta is a thrombopoietin (TPO) receptor agonist, and TPO receptor
agonists have been associated with thrombotic and thromboembolic
complications in patients with chronic liver disease. Portal vein
thrombosis has been reported in patients with chronic liver disease
treated with TPO receptor agonists. Consider the potential increased
thrombotic risk when administering Mulpleta to patients with known risk
factors for thromboembolism. Monitor platelet counts and for
thromboembolic events and institute treatment promptly.

Mulpleta should not be administered to patients with chronic liver
disease in an attempt to normalize platelet counts.

ADVERSE REACTIONS

The most common adverse reaction (≥ 3%) with Mulpleta was headache.

About Shionogi

Shionogi & Co., Ltd. is a major research-driven pharmaceutical company
dedicated to bringing benefits to patients based on its corporate
philosophy of "supplying the best possible medicine to protect the
health and wellbeing of the patients we serve." Shionogi's research and
development currently target two therapeutic areas: infectious diseases,
and pain/CNS disorders. For over 50 years, Shionogi has developed and
commercialized innovative oral and parenteral anti-infectives. In
addition, Shionogi is engaged in new research areas, such as
obesity/geriatric metabolic disease and oncology/immunology.
Contributing to the health and quality of life of patients around the
world through development in these therapeutic areas is Shionogi's
primary goal. For more details, please visit www.shionogi.co.jp/en/.
For more information on Shionogi Inc., the U.S.–based subsidiary of
Shionogi & Co., Ltd., headquartered in Florham Park, NJ, USA, please
visit www.shionogi.com.
For more information on Shionogi Ltd., the UK-based subsidiary of
Shionogi & Co. Ltd., headquartered in London, England, please visit www.shionogi.eu.

Forward Looking Statement

This announcement contains forward-looking statements. These
statements are based on expectations in light of the information
currently available, assumptions that are subject to risks and
uncertainties which could cause actual results to differ materially from
these statements. Risks and uncertainties include general domestic and
international economic conditions such as general industry and market
conditions, and changes of interest rate and currency exchange rate.
These risks and uncertainties particularly apply with respect to
product-related forward-looking statements. Product risks and
uncertainties include, but are not limited to, completion and
discontinuation of clinical trials; obtaining regulatory approvals;
claims and concerns about product safety and efficacy; technological
advances; adverse outcome of important litigation; domestic and foreign
healthcare reforms and changes of laws and regulations. Also for
existing products, there are manufacturing and marketing risks, which
include, but are not limited to, inability to build production capacity
to meet demand, unavailability of raw materials and entry of competitive
products. The company disclaims any intention or obligation to update or
revise any forward-looking statements whether as a result of new
information, future events or otherwise.

References:

       

1.

   

Peck-Radosavljevic M. Liver Int. 2017; 37(6):778-793.

2.

Giannini EG. Aliment Pharmacol Ther. 2006; 23(8):1055-1065.

3.

Koruk M, et al. Hepatogastroenterology. 2002; 49(48):1645-1648.

4.

Aref S, et al. Hematology. 2004; 9(5/6):351-356.

5.

Poordad F, et al. J Med Econ. 2012; 15:112-124.

6.

Hayashi H, et al. World J Gastroenterol. 2014; 20: 2595-2605.

 

USMUL-0027

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