Diovan approval with clean label unlikely, say analysts

The US Food and Drug Administration has until October 29 to decidewhether or not to approve Novartis' angiotenisn II receptor antagonist Diovan (valsartan) for the new indication of chronic heart failure, but analysts at Julius Baer have said that it is unlikely that the agency will clear it with a clean label.

An FDA advisory committee convened to discuss the application was split on the role of the drug in CHF at a review meeting on October 11 (Marketletter October 22). Although Novartis had been hoping to become the first company with an AIIRA approved for CHF, the analysts feel that the lack of any overall effect on mortality, coupled with the fact that there are risks associated with the drug's use in tandem with other medications, makes an approval this month unlikely.

"Even longer term, we consider it highly possible that approval will come only with a restrictive label," they add. Nevertheless, the analysts downplayed the impact of the disappointment, noting that even if Diovan is not approved for CHF, peak sales of the drug, estimated at more than 3 billion Swiss francs ($1.84 billion), would only be reduced by 200-300 million francs.