www.fdanews.com/articles/174571-nice-grants-prelim-approval-to-novartis-astellas-drugs-but-not-janssen-drug
NICE Grants Prelim Approval to Novartis, Astellas Drugs, but Not Janssen Drug
December 17, 2015
The UK’s health cost-benefit watchdog has given provisional approval in draft guidances for Novartis’ novel heart failure drug Entresto, and recommended Astellas’ enzalutamide as a treatment for prostate cancer.
Meanwhile, NICE withheld recommending Janssen’s prostate cancer drug Zytiga (abiraterone acetate), saying the drug is a well-tolerated treatment that delays chemotherapy, but that it was not convinced the “uncertain evidence” for the long-term treatment benefit justified the cost, which was “significantly above what it would normally consider acceptable.”