Norgine to provide NICE with additional information on Targaxan

Norgine has provided an update on the ongoing National Institute for Health and Care Excellence (NICE) approval process for its hepatic encephalopathy therapy Targaxan 550.

The company has received an appraisal consultation document from the UK regulator and has been asked to provide further clarification on certain aspects of its submission, which Norgine will provide before the end of the consultation period on December 18th 2013.

NICE's appraisal committee has acknowledged both the clinical effectiveness of Targaxan 550 and several cost-effectiveness arguments submitted by Norgine, in particular the health economic model it has detailed.

Peter Martin, chief operating officer at Norgine, said: "This treatment offers a significant advance as it can alleviate the substantial burden on patients, their families and healthcare systems and improve quality of life."

Hepatic encephalopathy is a serious and potentially life-threatening neuropsychiatric condition associated with liver disease that affects around 10,000 patients in the UK.

Targaxan 550 has been approved for the treatment of this disease within the Scottish NHS following a positive ruling from the Scottish Medicines Consortium in September 2013.