Eisai of Japan has been boosted by a US regulatory panel’s recommendation that the firm’s new sedative Aquavan should be approved.

The US Food and Drug Administration’s Advisory Committee on Anesthetic and Life Support Drugs has voted 6-3 in favour (with one abstention) of approval of Aquavan (fospropofol) injection for use as an intravenous sedative-hypnotic agent in adult patients undergoing diagnostic or therapeutic procedures. However the committee also voted 9-1 against allowing the drug to be administered by healthcare providers who are not appropriately trained.

Specifically the panel said that they were not convinced Aquavan, which Astellas acquired through its recent $3.9 billion purchase of MGI Pharma, could be safely used by medical personnel who did not have anaesthesia training. The advisory committee also recommended additional studies be conducted in specific patient populations, including those with a variety of comorbidities, for example in patients who weigh less than 60 kg and the elderly.

In total, data from 21 clinical studies involving 1,611 individuals are included in the application and these trials, which showed that Aquavan successfully sedated 69%-89% of patients, were conducted by nonanaesthesia health care professionals. Mary Lynne Hedley, executive vice president of Eisai in North America, said the firm still believes “the clinical trial data support the use of this product by anaesthesiologists and non-anaesthesia health care professionals”.

The FDA usually follows the recommendations of its advisory panels and a final decision on the drug is expected by July 26. An approval would be the first in the USA for Eisai since 1999 when it got the go-ahead to market the proton pump inhibitor Aciphex (rabeprazole).