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Benlysta granted priority FDA review

The US FDA has granted a priority review designation for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus

GlaxoSmithKline (GSK) and Human Genome Sciences (HGS) have announced that the US Food and Drug Administration (FDA) has granted a priority review designation for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus (SLE).

A priority review designation is granted to drugs that, if approved, offer major advances in treatment or provide a treatment where no adequate therapy exists. The FDA has assigned belimumab a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010.

The Biologics License Application (BLA) for belimumab was submitted to the FDA on June 9, 2010, and includes the results of two pivotal phase III clinical trials that treated a total of 1,684 autoantibody-positive patients with SLE.

HGS designed the phase III programme for belimumab in collaboration with GSK and leading international SLE experts, and in consultation with the FDA.

"We are very pleased that FDA has chosen to grant priority review to belimumab, the first in a new class of drugs called BLyS-specific inhibitors," said H Thomas Watkins, president and chief executive officer, HGS.

"We believe that the priority review designation speaks both to the significant medical need of people living with lupus and to the potential belimumab may hold as a new treatment option for these patients."

Benlysta is a human, monoclonal antibody that stops the binding of BLyS to B cells, inhibiting the proliferation of B cells. Researchers have found that BLyS not only induces B-lymphocyte maturation, but can also enhance autoantibody production. Overexpression of BLyS in mice resulted in an autoimmune-like response.

Human studies have shown BLyS levels change overtime in most people with lupus. Additionally, increases in BLyS levels have been linked to increased in disease activity (flares), making researchers believe that BLyS may be a biomarker of SLE.

Studies have shown that Benlysta is more effective in active disease, especially moderate to severe lupus. Since it has not yet been FDA approved, dosing and frequency of administration are still undetermined.

However, studies have initially been using an intravenous infusion at zero, two and four weeks. After the first month, dosing was reduced to once monthly infusions. Studies have reported mild side effects, with the main side effect being urticaria (itching).

Benlysta is used with standard of care treatment, including Plaquenil (hydroxychloroquine), methotrexate, steroids, and immunosuppressants such as mycophenalate. Most medicines used for lupus are considered off-label, meaning they have not been FDA approved for use in lupus.

23rd August 2010

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