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US approval for GSK's lupus treatment Benlysta

Published on 10/03/11 at 11:32am
systemic lupus erythematosus (SLE)
Light micrograph of a section through a glomerulus (blood filtration structure) from kidney tissue in a case of SLE

GlaxoSmithKline’s lupus treatment Benylsta has won an historic approval in the US, but will have to prove its safety record once it hits the market later this month.

It is the first new lupus treatment licensed by the FDA in more than 50 years and the regulator fast-tracked its review in recognition of its potential to be a major advance in the disease area.

Benlysta (belimumab) can be used to treat adults with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy, and GSK and marketing partner Human Genome Sciences expect to launch it before the end of March

Moncef Slaoui, chairman of 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 US”

Lupus is a potentially fatal, autoimmune disease and there are around 300,000 to 1.5 million sufferers in the US. It disproportionately affects women, and African American women in particular - with three times as many new cases of the disease occurring in this group compared to Caucasian women.

Benlysta's post-marketing requirements

Following its priority review Benlysta will have to stand up to extended post-marketing data requirements as a matter of course, but the FDA also wants more safety and efficacy information and stronger warnings for patients about side effects.

GSK and HGS will have to produce a Medication Guide to inform patients of the risks associated with Benlysta and conduct an additional clinical trial to further evaluate its safety and effectiveness in a particular subgroup of patients.

The trial requirement follows in the wake of two studies involving African American patients and patients of African heritage in which they did not appear to respond to treatment with Benlysta.

The FDA noted those studies lacked sufficient numbers to establish a definite conclusion and GSK agreed to conduct an additional study of people with those backgrounds.

HGS and GSK have been co-developing Benlysta since 2006 and HGS was responsible for its phase III trials, with assistance from GSK. The partners will equally share phase III/IV development costs, sales and marketing expenses, as well as the drug’s profits.

“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, 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.”  

The companies submitted Benlysta to European regulators in June 2010, and further applications have been made in Canada, Australia, Switzerland, Russia, Brazil and the Philippines.

Dominic Tyer

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