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Benlysta to be fast-tracked by FDA

Published on 20/08/10 at 10:03am


New lupus drug Benlysta has been given priority review status by the FDA.

Benlysta (belimumab) has been developed by Human Genome Science and GSK for systemic lupus erythematosus (SLE), a chronic inflammatory disease of the connective tissue that affects the entire body.

The priority review reflects Benlysta’s potential to be a major advance in the disease area. Current treatment options are limited, with corticosteroid injections and non-steroidal anti-inflammatory drugs (NSAIDs) aimed primarily at reducing inflammation or other related symptoms.

Analysts predict the drug to be a blockbuster, with Evaluatepharma projecting sales of $2.74 billion from 2016.

The US regulator could approve the treatment within six months, but Benlysta will have to stand up to extended post-marketing data requirements if it is approved under this system.

This could prove problematic for the drug, as Benlysta has had a mixed bag of phase III results in recent months.  

The companies filed the drug with the EMA in June and will hope to have the treatment on the market in 2011.

Carlo Russo, senior vice president, biopharm development, GSK, said: “Belimumab is the first medicine for lupus that has completed phase III trials with positive results.  We look forward to continuing to work together with HGS to progress regulatory files and we hope that we will be able to deliver a new treatment option for patients living with lupus.

H. Thomas Watkins, president and chief executive of HGS, said:  “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.”

“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 works by inhibiting BLyS, a naturally occurring protein which helps the survival and development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body’s first line of defence against infection.

In lupus, elevated levels of BLyS are believed to contribute to the production of auto-antibodies – antibodies that attack and destroy the body’s own healthy tissues. The results of prospective observational studies show a correlation of elevated levels of BLyS with SLE disease activity.

Ben Adams

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