GlaxoSmithKline and Human Genome Sciences announce FDA approval of Benlysta® (belimumab) for the treatment of systemic lupus erythematosus

• First new approved drug for systemic lupus in more than 50 years. To be available to physicians and patients before the end of March.

Issued: London UK & Rockville, Maryland, US

GlaxoSmithKline plc (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that the U.S. Food and Drug Administration (FDA) has approved Benlysta^® (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

The US label includes the following limitations of use:  The efficacy of belimumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, and has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of belimumab is therefore not recommended in these situations.

Moncef Slaoui, Ph.D., Chairman, GSK Research and Development, said, “The approval of Benlysta is an important step for appropriate lupus patients. Patients have been waiting for new treatment options to help manage this chronic disease. We look forward to working together with HGS to bring this new medicine to patients in the U.S.”

“We and GSK are honoured to have the opportunity, with the approval of FDA, to bring Benlysta forward in the United States as the first new drug for systemic lupus in more than 50 years,” said H. Thomas Watkins, President and Chief Executive Officer, HGS.  “We expect to have this novel therapy available to physicians and patients within about two weeks, and our entire organisation looks forward to the positive impact we hope this new therapy will have for patients with systemic lupus.”  

Full US prescribing information.  

Medication guide for Benlysta (belimumab).

Important Safety Information

Benlysta (belimumab) is contraindicated in patients who have had anaphylaxis with belimumab. 

There were more deaths reported with belimumab than with placebo during the controlled period of the clinical trials. Out of 2133 patients in 3 clinical trials, a total of 14 deaths occurred during the placebo-controlled, double-blind treatment periods: 3/675 (0.4%), 5/673 (0.7%), 0/111 (0%), and 6/674 (0.9%) deaths in the placebo, belimumab 1 mg/kg, belimumab 4 mg/kg and belimumab 10 mg/kg groups, respectively.  No single cause of death predominated.  Etiologies included infection, cardiovascular disease, and suicide.   

Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including belimumab.  In controlled clinical trials, serious infections occurred in 6.0% of patients treated with belimumab and in 5.2% of patients who received placebo.  The most frequent serious infections included pneumonia, urinary tract infection (UTI), cellulitis, and bronchitis. The most frequent infections (>5%) were upper respiratory tract infection, UTI, nasopharyngitis, sinusitis, bronchitis, and influenza. 

The impact of treatment with belimumab on the development of malignancies is not known.  As with other immunomodulating agents, the mechanism of action of belimumab could increase the risk for developing malignancies. 

Hypersensitivity reactions were reported in 13% of patients receiving belimumab and 11% of patients receiving placebo, and included anaphylaxis (0.6% with belimumab and 0.4% with placebo).  Infusion-associated adverse events were reported in 17% of patients receiving belimumab and 15% of patients receiving placebo.  Serious infusion reactions included bradycardia, myalgia, headache, rash, urticaria, and hypotension.  The most common infusion reactions (>3%) were headache, nausea, and skin reactions. 

Psychiatric events (primarily depression, insomnia, and anxiety) were reported more frequently with belimumab (16%) than with placebo (12%).  Serious psychiatric events (0.8% for belimumab and 0.4% for placebo), serious depression and two suicides were also reported.  It is unknown if belimumab treatment is associated with increased risk for these events. 

The most commonly reported adverse reactions (=5%) with belimumab were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.

About Benlysta

Benlysta (belimumab) is the first in a new class of drugs called BLyS-specific inhibitors.   Belimumab blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells. Belimumab does not bind B cells directly, but by binding BLyS, belimumab inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. BLyS is a naturally occurring protein which was discovered by HGS in 1996.

Benlysta is made available as a lyophilised powder in single-use vials for intravenous infusion only and must be reconstituted and diluted by a healthcare professional prior  to administration.

GSK submitted a Marketing Authorisation Application (MAA) for Benlysta to the European Medicines Agency (EMA) in June 2010. Regulatory applications have also been submitted and are currently under consideration in Canada, Australia, Switzerland, Russia, Brazil and The Philippines.

About the GSK/HGS collaboration

HGS and GSK are developing belimumab under a definitive co-development and co-commercialisation agreement entered into in 2006.  Under the agreement, HGS had responsibility for conducting the belimumab Phase III trials, with assistance from GSK. The companies share equally in Phase III/IV development costs, sales and marketing expenses, and profits of any product commercialised under the current agreement.

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  GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease. 

Human Genome Sciences exists to place new therapies into the hands of those battling serious disease.

For more information about HGS, please visit the Company’s web site at www.hgsi.com. HGS, Human Genome Sciences and Benlysta are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.

GlaxoSmithKline cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, 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 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2010.

HGS safe harbour statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences’ current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of Human Genome Sciences’ unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials and regulatory approvals, Human Genome Sciences’ ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with facilities, intense competition, the uncertainty of patent and intellectual property protection, Human Genome Sciences’ dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company’s filings with the SEC.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date.  Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.