Lilly's Xigris has been recommended by NICE to treat adults with severe sepsis that has resulted in multiple organ failure.

Sepsis is an exaggerated immune response to infection, most commonly due to hospital acquired bacterial infections, including the notorious 'super bug' MRSA. Severe sepsis is defined by abnormally low blood pressure (hypotension) or hypoperfusion, where blood is unable to pass through tissue, usually because of abnormal clotting. These can in turn interfere with circulation and lead to multiple organ failure.

Current management of severe sepsis involves treating the underlying infection with antibiotics and other measures such as fluids, vasopressors, breathing and renal support but 30 to 50% of patients with the condition still die.

NICE says the 21,000 cases of severe sepsis every year represents 27% of all admissions to intensive care units, and 46% of all ICU bed days. The Institute recommends that the drug should only be initiated and supervised by a specialist consultant with experience of intensive care and treating patients with sepsis.

Dr Saxon Ridley, president of the Intensive Care Society (ICS) and consultant intensivist at the Norfolk and Norwich University Hospital said: "Severe sepsis is a devastating, extremely complex infection. The ICS welcomes the NICE guidance for Xigris, which should result in critical care consultants having wider access to this life-saving drug and so improving patient treatment and lowering mortality rates."

Andrea Sutcliffe, planning and resources director and NICE executive lead for the appraisal said: "Currently, as many as half of the patients who develop severe sepsis die. Today's guidance represents a major step forward for the treatment of patients with severe sepsis that has resulted in multiple organ failure."

Lilly has welcomed the news, and says evidence suggests the cost of Xigris (drotrecogin alfa) is in line with other interventions carried out in the ICU. Studies have shown that the cost per life year saved is £4,716 and cost per QALY (quality adjusted life year) is £6,385.

Trials have shown the drug improves mortality rates by 7.4% in patients with two or more organs in failure.

Xigris was launched in the UK in August 2002 and is the only drug licensed for the specific treatment of severe sepsis. Analysts Deutsche Bank say they expect Xigris worldwide sales to grow 39% annually over the next three years, reaching $430 million by 2006.

The drug is a genetically engineered form of human activated protein C, a molecule involved in reducing blood clotting and inflammation.

pharmafocus@pharmafile.co.uk