GlaxoSmithKline announces start of phase III study of Benlysta® (belimumab ) in patients with vasculitis

Issued: Wednesday 3 April 2013, London UK

GlaxoSmithKline plc (GSK) today announced the start of a Phase III study to evaluate Benlysta® (belimumab) in patients with ANCA (Anti-neutrophil Cytoplasmic Antibodies) positive vasculitis – a condition that involves inflammation of the blood vessels.

The multi-centre, multi-national, randomised, double-blind study will evaluate the efficacy and safety of belimumab in combination with azathioprine for the maintenance of remission in patients with a particular type of vascultitic disease called ANCA associated Vasculitis (Granulomatosis with Polyangiitis (Wegener’s) or microscopic polyangiitis).

Belimumab is not approved for use anywhere around the world for vasculitic disease.

About vasculitis
Vasculitis is a condition where the body's immune system attacks blood vessels leading to inflammation of the blood vessels. This results in disruption of blood flow which can in turn damage the body's organs. The signs and symptoms of vasculitis vary depending upon which organs have been damaged and the extent of the damage.

Vasculitic diseases are classified according to the predominant size of vessel involved.ANCA - associated vasculitis is the most common primary systemic small-vessel vasculitis to occur in adults. Granulomatosis with Polyangiitis (Wegener’s) and Microscopic Polyangiitis are two classifications of ANCA-vasculitis with a combined estimated prevalence of 102 – 284 per milllion in the US and 178-284 per million in Europe.

About Benlysta (belimumab)

Belimumab is the first in a drug class known as BLyS-specific inhibitors. It was first approved by the U.S. Food and Drug Administration in 2011 for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE or lupus) who are receiving standard therapy.  It was also approved by the European Commission in 2011 as add-on therapy in adult patients with active, autoantibody-positive SLE with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy. Its use has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, HIV, a history of, or current, hepatitis B or C, hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl), a history of major organ transplant or hematopoietic stem /cell /marrow transplant or renal transplant; and it has not been studied in combination with other biologics or intravenous cyclophosphamide. Its use is not recommended in these situations.

Important Safety Information

Benlysta (belimumab) is contraindicated in patients who have had anaphylaxis with belimumab. Additional risks include: Mortality: There were more deaths reported with belimumab than with placebo during the controlled period of clinical trials; Serious Infections: Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including belimumab. Use with caution in patients with chronic infections. Consider interrupting belimumab therapy if patients develop a new infection during belimumab treatment; Malignancy:  As with other immunomodulating agents, the mechanism of action of belimumab could increase the risk of malignancies;  Hypersensitivity Reactions, Including Anaphylaxis: Serious and fatal reactions have been reported. Belimumab should be administered by healthcare providers prepared to manage anaphylaxis. Monitor patients during and for an appropriate period of time after administration of belimumab; Depression: Depression and suicidality have been reported in belimumab studies. Patients should be instructed to contact their healthcare provider if they experience new or worsening depression,suicidal thoughts or other mood changes; Immunization: Live vaccines should not be given concurrently with belimumab; Adverse Reactions: Common adverse reactions (≥5%) in clinical trials were: nausea, diarrhea,pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.

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

Benlysta is a registered trade mark of the GlaxoSmithKline group of companies.

GlaxoSmithKline Enquiries:

 

 

 

UK Media enquiries:

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Sarah Spencer

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Analyst/Investor enquiries:

Ziba Shamsi

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Lucy Budd

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Tom Curry

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Gary Davies

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James Dodwell

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Jeff McLaughlin

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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.

 

This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.