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FDA take hard line on GSK lupus drug

Reviewers at the US Food and Drug Administration have taking a hard line on lupus drug Benlysta ahead of an advisory committee meeting

Internal reviewers at the US Food and Drug Administration (FDA) have offered a tough assessment of Human Genome Sciences (HGS) and GlaxoSmithKline's (GSK) lupus drug Benlysta (belimumab) in briefing documents prepared in advance of a November 16 advisory committee meeting at which outside advisors will vote on whether to recommend FDA approval of the drug.

The reviewers' assessment is generally positive and is not likely to be a serious blow for Benlysta, which is widely regarded as a potential blockbuster with good odds of winning marketing approval. However, the briefing does raise questions about whether the drug's efficacy is sufficient to offset the risks it may pose of suicide, infection and cancer.

Benlysta, which was developed by HGS, inhibits the production of antibodies that attack healthy cells in lupus patients. It met its primary endpoints in two phase III trials. However, the FDA staff reviewers said in their report that "the robustness and the clinical meaning of the findings warrant discussion." One concern raised in the briefing is the drug's failure to demonstrate efficacy in black patients, which is particularly pertinent because the disease is three times as common in black women as in white women.

Working in the companies' favour is the dire need for new lupus therapies. If it is approved, Benlysta will be the first new treatment for the potentially fatal disease to hit the market since 1958. Other companies that have tried to enter the market in recent years have been unsuccessful. For example, Roche's Rituxan (rituximab), which is approved for rheumatoid arthritis, leukaemia and non-Hodgkin's lymphoma, failed a late-stage lupus trial last year.

Benlysta would offer a potentially important alternative to currently approved drugs, which include antimalarial drugs that were cleared for the lupus indication decades ago and prednisone, a steroid that can have debilitating side effects when used long-term. The chemotherapy drug cyclophosphamide and Roche's immunosuppressant drug CellCept (mycophenolate mofetil) are often used off-label for lupus but have not been approved for the indication by the FDA.

However, while Benlysta's novel method of action means the drug could offer a long-awaited new approach to treating the disease, it also means that reviewers need to be especially cautious in reviewing the data, the staff report suggests.

The companies expect a decision on the drug by December 9, under the FDA's priority review programme, which aims to make a decision on marketing applications for important new therapies within six months of submission.

About 1.5m Americans have lupus. Analysts have predicted that if the drug is approved, annual sales could top $2.1bn after its first few years on the market.

HGS and GSK entered into a co-development and commercialisation agreement for Benlysta in 2006. Under the terms of that deal, the companies will share equally in late-stage development costs, sales and marketing expenses, and profits.

15th November 2010

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