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FDA Review Of Novartis' Entresto Shows Agency's Practical Side

 
• By Bridget Silverman

Pivotal trial of Novartis' sacubitril/valsartan duo in heart failure did not conform to FDA's combination policy, but agency ultimately valued its mortality effect over statistical correctness.

The mortality benefit seen in the pivotal trial of Novartis AG's heart failure therapy Entresto (valsartan and sacubitril) went a long way toward overcoming FDA's reservations about the new drug application's failure to establish the efficacy contribution of each component under the agency's policy on combination drug development.

"The review team is not unanimous in the policy decision we made," Division of Cardiovascular and Renal Products Director Norman...

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