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GSK receives positive CHMP opinion for REVOLADE in thrombocytopenia associated with chronic hepatitis C infection

GSK announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for Revolade™ (eltrombopag).

Issued: London UK

Today, GlaxoSmithKline plc (GSK) announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for Revolade™(eltrombopag) as a treatment for low platelet counts (thrombocytopenia) in adult patients with chronic hepatitis C infection, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy.

“A sustained virologic response is the goal for treatment of hepatitis C infection and our clinical study, the largest ever in cirrhotic patients with low platelet counts and chronic hepatitis C infection, demonstrated that eltrombopag in combination with interferon-based therapy, allowed more cirrhotic patients with low platelet counts to reach this goal.” said Dr Rafael Amado Head of Oncology R&D, GlaxoSmithKline.  “We’re looking forward to working with the regulators to attain full marketing authorisation for this indication.”  

The CHMP opinion is based on review of safety and efficacy data for eltrombopag, including two randomised, double-blind, placebo controlled, multi-centre Phase III studies of more than 1500 patients.

A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, but does not always result in marketing authorisation.

More about thrombocytopenia related to chronic Hepatitis C infection: Hepatitis C virus (HCV) infection is the most common blood borne viral infection, affecting up to 170 million people world-wide. Chronic HCV infection is associated with chronic liver disease which can lead to a number of blood-related disorders including low platelet count (thrombocytopenia).  Treatment with pegylated interferon and ribavirin is the current standard of care for patients with HCV, however both the European Association for the Study of the Liver guidelines and the American Association for the Study of Liver Diseases report the presence of thrombocytopenia among the relative contraindications to antiviral therapy [i], [ii]. 

More about RevoladeTM (eltrombopag): In the European Union (EU), eltrombopag is currently approved as a treatment for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP).  In the US, eltrombopag is marketed under the trade name PROMACTA® and is currently approved as a treatment for patients with chronic immune (idiopathic) thrombocytopenia who have had insufficient response to corticosteroids, immunoglobulins, or splenectomy and as a treatment for thrombocytopenia in patients with chronic hepatitis C infection to allow the initiation and maintenance of interferon-based therapy.  

The most important serious adverse reactions identified in the ITP or HCV trials were hepatotoxicity, including hepatic decompensation events and thrombotic/thromboembolic events.

The most common adverse reactions (experienced by at least 10 % of patients) of any grade in the ITP or HCV trials included; headache, anaemia, decreased appetite, insomnia, cough, nausea, diarrhoea, alopecia, pruritus, myalgia, pyrexia, fatigue, influenza like illness, asthenia, chills and peripheral oedema.

For the full EU Summary of Product Characteristics for RevoladeTM and full US Prescribing Information, including BOXED WARNING and Medication Guide for Promacta® and please visit http://www.gsk.com/en-gb/products/

Important safety information for RevoladeTM

There is an increased risk for adverse reactions, including potentially fatal hepatic decompensation and thromboembolic events, in thrombocytopenic HCV patients with advanced chronic liver disease, as defined by low albumin levels = 35 g/L or MELD score = 10, when treated with eltrombopag in combination with interferon based therapy. Treatment with eltrombopag in these patients should be initiated only by physicians experienced in the management of advanced HCV, and only when the risks of thrombocytopenia or withholding antiviral therapy necessitate intervention. If treatment is considered clinically indicated, close monitoring of these patients is required.

Risk of hepatotoxicity

Eltrombopag administration can cause abnormal liver function. Liver enzyme elevations have been reported in the ITP and HCV populations. Most patients being treated with eltrombopag in combination with peginterferon/ribavirin will experience indirect hyperbilirubinaemia. Hepatic enzymes should be measured prior to the initiation of eltrombopag therapy. Discontinue therapy if liver enzymes do not stabilize or are accompanied by worsening liver function

Hepatic decompensation (use with interferon)

Chronic HCV patients with cirrhosis may be at risk of hepatic decompensation when receiving alpha-interferon therapy. Hepatic decompensation was reported in controlled clinical studies in thrombocytopenic patients with HCV treated with eltrombopag in combination with interferon-based antiviral therapy. Patients should be monitored closely for signs and symptoms suggestive of hepatic decompensation, in particular, ascites, hepatic encephalopathy and variceal haemorrhage. Eltrombopag therapy should be terminated if antiviral therapy is discontinued for hepatic decompensation.. Patients with poor liver function at baseline [albumin =35g/L or MELD score = 10] should be closely monitored.

Thrombotic/Thromboembolic complications

Venous and arterial thrombotic/thromboembolic complications have occurred with eltrombopag therapy. Portal vein thrombosis was the most common thromboembolic event reported in controlled clinical studies in thrombocytopenic patients with HCV. Patients with poor liver function at baseline are at increased risk of thromboembolic events. Patients should be monitored closely for signs and symptoms suggestive of thromboembolic events.

Combination with direct acting antiviral agents

Safety and efficacy have not been established in combination with direct acting antiviral agents approved for treatment of chronic hepatitis C infection.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.

References

[i]   European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol 2011; 55: 245–64.

[ii]   Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009; 49: 1335–74.