Please login to the form below

Not currently logged in
Email:
Password:

FDA approves GSK lupus drug

GSK and Human Genome Sciences have  announced US Food and Drug Administration approval of their lupus drug Benlysta
Administration approval of their lupus drug Benlysta (belimumab), marking the first approval of a new drug for the disease in the US in 50 years.

Specifically, the FDA has approved Benlysta for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.
The approval came without restrictions for use in African-American patients, despite the fact that they did not appear to respond to treatment with Benlysta in clinical studies. The issue is significant, as African-American women have a rate of the disease that is three times higher than Caucasian women.

The FDA said it had determined that there was not enough data in African-Americans to establish a definite conclusion on the matter. As a condition of the approval, the companies will conduct an additional study in the population.

Benlysta, which was developed by HGS, inhibits the production of antibodies that attack healthy cells in lupus patients. The drug is delivered via intravenous infusion. The companies said the therapy will be available to physicians and patients before the end of March.

A consensus forecast complied by Thomson Reuters found that analysts believe global sales of the drug could top $3 billion by 2015.  GSK and HGS signed a co-development and co-commercialisation agreement in 2006 under which they will share equally in sales and marketing expenses, as well as profits.

GSK submitted a Marketing Authorisation Application for Benlysta to the European Medicines Agency in June 2010. The drug has also been filed for approval in Canada, Australia, Switzerland, Russia, Brazil and The Philippines.

The drug's approval in the US was far from a foregone conclusion.  In late 2010, an FDA advisory committee recommended that the agency grant marketing approval, but raised a number of concerns about the drug, including misgivings about a lack of robustness in its efficacy data.

The advisory committee members' conclusion that the drug deserves approval but is not necessarily a major advance in treatment was in line with the stance taken by the FDA's internal reviewers in briefing documents prepared in advance of the committee meeting. The internal reviewers' assessment was generally positive but raised questions about whether the drug's efficacy is sufficient to offset the risks it may pose of suicide, infection and cancer.

10th March 2011

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Jet Off with Maloff Protect

Latest intelligence

How ‘Greenwashing’ accusations could delay the very changes its supporters demand
Are shouts of companies ‘greenwashing’ to provide a façade of environmental and ethical respectability causing more harm than good? Or should we call out practices that we believe are papering...
What does the future hold for clinical trial recruitment?
The past couple of years have raised several aspects of healthcare in the public’s consciousness – and one of the leading ones has been the role of clinical trials in...
When is an agency not an agency?
The PR Week UK Top 150 Consultancies prompts anticipation and curiosity. But can a virtual collective of freelancers fairly be compared and ranked against conventional agencies?...