Novartis files sNDA with FDA for Diovan

Novartis Pharmaceuticals has filed a supplemental New Drug Applicationwith the US Food and Drug Administration for Diovan (valsartan), its angiotensin II receptor antagonist currently sold as a first-line treatment for hypertension, for the treatment of heart failure. Filings for this new indication are also being initiated with the regulatory authorities in major international markets.

The sNDA submission is based on positive findings of the Valsartan Heart Failure Trial which demonstrated that Diovan significantly reduced morbidity by 13.2% when compared to usual therapy in heart failure patients such as ACE inhibitors, beta blockers, diuretics, and digoxin. Diovan also significantly reduced HF hospitalizations by 27.5% compared to standard therapy (Marketletter November 20, 2000).

The AIIRAs have not enjoyed the same ease towards the market for heart failure that was a feature of their forerunners, the ACE inhibitors, and valsartan is the first drug in the class to reach the filing stage. Previous efforts by firms with AIIRAs on the market, including Merck & Co and AstraZeneca, have failed to provide compelling results in HF (Marketletters passim), though ongoing studies may change this situation.