| HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE FDA APPROVAL OF BENLYSTA® (BELIMUMAB) FOR TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS | |
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ROCKVILLE, Maryland, and LONDON, UK – March 9, 2011 – Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) 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 label for BENLYSTA 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. “We and GSK are honored 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 organization looks forward to the positive impact we hope this new therapy will have for patients with systemic lupus.” 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.” For full BENLYSTA (belimumab) prescribing information, please click here. For the medication guide for BENLYSTA, please click here. IMPORTANT SAFETY INFORMATION
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 is made available as a lyophilized 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 Authorization 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. CONFERENCE CALL
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For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it or by calling HGS at (877) 822-8472. HGS, Human Genome Sciences and BENLYSTA are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners. HGS SAFE HARBOR STATEMENT
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