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24-Dec-2018

Shionogi : Receives Positive Opinion for Lusutrombopag in Latest Announcement from the Committee for Medicinal Products for Human Use (CHMP)

Shionogi Receives Positive Opinion for Lusutrombopag in Latest Announcement from the Committee for Medicinal Products for Human Use (CHMP)

OSAKA, Japan, and LONDON, UK, 18 December 2018 - Shionogi & Co., Ltd. (hereafter "Shionogi"), a research-driven pharmaceutical company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorisation for lusutrombopag for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) undergoing invasive procedures.

The European Commission will issue a Decision in due course for the use of lusutrombopag, taking into account the recommendation from the CHMP.

Welcoming the announcement, Dr. John Keller, Chief Executive Officer of Shionogi Ltd., said: "This CHMP positive opinion is an important milestone for patients in Europe living with chronic liver disease, bringing a well-tolerated and effective treatment option for severe thrombocytopenia that facilitates the management of invasive procedures one step closer to these patients."

CLD is a major public health issue, affecting approximately 29 million people in Europe,1 and is an increasing cause of morbidity and mortality worldwide2. Thrombocytopenia is the most common blood-related complication of CLD, occurring in up to 78% of patients with the condition.3 Severe thrombocytopenia is less common, occurring in up to 11% of patients4. In patients with severe thrombocytopenia who require an elective invasive procedure, there is an increased risk of bleeding and subsequent need for platelet cover, which is currently provided through platelet transfusions.5,6

The Marketing Authorisation application for lusutrombopag was based on two pivotal Phase 3 randomised clinical trials, L-PLUS1 and L-PLUS2, where 312 patients with CLD, severe thrombocytopenia with a platelet count of <50,000/┬ÁL and a scheduled invasive procedure received either lusutrombopag or placebo once daily for up to seven days7,8. Lusutrombopag met the pre-specified primary and all key secondary endpoints with statistically significant results.

In L-PLUS1, 75.5% (37/49) of patients receiving lusutrombopag required no platelet transfusion prior to the primary invasive procedure or rescue therapy for bleeding within seven days post-procedure, compared with 12.5% (6/48) who received placebo (P< 0.0001)9. In L-PLUS2, 64.8% (70/108) of patients who received lusutrombopag required no platelet transfusion prior to the primary invasive procedure or rescue therapy for bleeding within seven days post-procedure, compared to 29% (31/107) receiving placebo (P< 0.0001)9. The most common adverse reactions were headache, nausea, portal vein thrombosis and rash; the frequency of portal vein thrombosis was comparable between lusutrombopag and placebo treatment groups.

Lusutrombopag, which has already been approved for routine use in the US10 and Japan11, is an orally active, small molecule agonist of the human thrombopoietin receptor that triggers the production of endogenous platelets, taken once daily in tablet form for 7 days. It has been granted Promising Innovative Medicine Designation (PIM) by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), confirming its potential for CLD patients with severe TCP undergoing an invasive procedure.

Media contact

For further information or to arrange a spokesperson interview please contact: Dr. Mark Hill, Shionogi, mark.hill@shionogi.eu

Beth Whitworth, Golin Health, bwhitworth@golin.com,+44 20 3900 6006, +44 (0) 7387 107197

About Thrombocytopenia in Chronic Liver Disease

Thrombocytopenia is a common complication of chronic liver disease (CLD) and may be caused by multiple mechanisms including splenic sequestration and decreased production of thrombopoietin3. There is evidence that the annual health care cost of a CLD patient with thrombocytopenia is more than three times that of a CLD patient without thrombocytopenia6. In addition to the potential of thrombocytopenia, especially severe thrombocytopenia, to aggravate procedural 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.12

About Shionogi

Shionogi & Co., Ltd. ("Shionogi") is a Japanese 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." The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders, cardiovascular diseases and gastroenterology. Shionogi's research and development currently target two therapeutic areas: infectious diseases and pain/CNS disorders.

For more information on Shionogi, please visit http://www.shionogi.co.jp/en/.

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 Blachier M et al. J Hepatol. 2013, 58(3): 593-608.

2 Marcellin, P. & Kutala B. Liver Int. 2018;38(Suppl. 1):2-6.

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

4 De Gottardi, A. et al. Clin Gastroenterol Hepatol. 2009 Aug;7(8):906-9

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

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

7 Hidaka H, et al. Clin Gastro Hepato. 2018.

8 Peck-Radosavljevic M, et al. United Eur Gastro Jour. 2017. 5(8): 1138-1150.

9 Shionogi data on file, 14 December 2018

10https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210923Orig1s000Approv.pdf

11http://www.info.pmda.go.jp/go/pack/3399010F1022_1_02/

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

Editor Details

Last Updated: 24-Dec-2018