LONDON More research is needed to assess the effectiveness of Daxas, a new lung drug developed by Nycomed and marketed in Europe by U.D. group Merck & Co, Britain's health cost watchdog said on Friday.
The National Institute for Health and Clinical Excellence said there was "great uncertainty" about how well it worked as a add-on to other treatments for COPD, or smoker's lung, and it was not able to establish whether the drug was worth using on the state health service.
Draft guidance from the watchdog recommended setting up a further clinical trial to assess the pill, also known as roflumilast, as an add-on to triple or dual therapy for people with bad chronic obstructive pulmonary disease (COPD).
"While we recognise it is important for people with severe COPD to have a range of options, NICE has to ensure that the NHS (National Health Service) provides treatments which are effective and value for money," said NICE Health Technology Evaluation Centre Director Carole Longson.
"We hope a clinical study would generate robust evidence so that we can be clear about the benefits roflumilast brings for these patients."
Japan's largest drugmaker Takeda Pharmaceutical agreed to buy privately held Nycomed for 9.6 billion euros (8 billion pounds) in May, partly to gain access to the newly approved medicine.
Daxas is known by the brand name Daliresp in the United States, where Forest Laboratories has the marketing rights.
(Reporting by Ben Hirschler; Editing by Dan Lalor)