AZ's clotbuster wins prelim nod from NICE

Britain's cost-effectiveness watchdog has given the thumbs up to AstraZeneca's new blood thinner, Brilique. Awaiting approval under the brand name Brilinta in the U.S., Brilique won a preliminary endorsement from the U.K.'s National Institute for Health and Clinical Excellence, which assesses the costs and benefits of new meds.

If NICE's preliminary nod bears out, it would be a boost for Brilique, which is designed to be paired with aspirin in patients with acute coronary syndromes, Reuters points out. That includes people who've had problems such as heart attacks. NICE's Carole Longson said the agency's recommendation was based on data suggesting Brilique outperformed the current standard therapy, the Bristol-Myers Squibb and Sanofi drug Plavix.

According to Longson, clinical data suggests that, in comparison with Plavix, Brilique cut heart attacks by 16 percent and reduced deaths from vascular causes by 21 percent. Plus, Brilique didn't show a significant difference in bleeding risk. Outperforming Plavix is key to Brilique's future, because the BMS-Sanofi drug is headed for the patent cliff, and cheaper copies will quickly hit the market. To compete, Brilique has to have another edge.

Of course, the AstraZeneca drug's success also hinges on its winning approval in the U.S. That decision is expected later this month. FDA has delayed approval in part because of data showing the drug is less effective in North American patients. That difference, however, may be attributable to higher aspirin doses in North America, as a new study recently found.

- get the release from NICE
- see NICE's preliminary appraisal
- read the Reuters news