NICE asks for more data on Merck/Nycomed COPD drug

The U.K.'s cost-effectiveness watchdog has cast a skeptical eye on Merck ($MRK) and Nycomed's new lung drug Daxas. In draft guidance, the National Institute for Health and Clinical Excellence said more data was needed for it to be convinced the treatment was a good value for use in chronic obstructive pulmonary disease, or COPD.

NICE said it saw "great uncertainty" about how well Daxas works as an add-on treatment in COPD patients, Reuters reports. The agency recommended a new clinical trial to look at the drug's benefit as an add-on to treatment to two or three other drugs in patients with severe smoker's lung. NICE suggested comparing Daxas with theophylline treatment as well.

"While we recognize it is important for people with severe COPD to have a range of options, NICE has to ensure that the [National Health Service] provides treatments which are effective and value for money," the agency's Carole Longson said. "We hope a clinical study would generate robust evidence so that we can be clear about the benefits [Daxas] brings for these patients."

If NICE doesn't reconsider, it would be a blow to Takeda Pharmaceutical. The Japanese company agreed to buy Switzerland's Nycomed partly to gain access to Daxas, which recently won approval, as Reuters notes.

- read the release from NICE
- see the Reuters news

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