By Susan Comninos
NEW YORK (Reuters Health) – The US Food and Drug Administration has issued an approvable letter for Novartis Pharmaceuticals' antihypertensive Diovan (valsartan) as an adjunct to heart failure therapeutics for patients not on an ACE inhibitor, the firm said on Thursday.
Diovan, a highly selective angiotensin II receptor blocker (ARB), is indicated as a first-line therapy for hypertension in 80 nations, including the US, the firm said.
The FDA's approvable letter represents a milestone on the path to develop Diovan for additional indications, including diabetes and other cardiac problems, Novartis Pharmaceuticals Corp. President and CEO Paulo Costa noted.
The agency's decision comes in response to a supplemental new drug application filed by the firm based on its Valsartan Heart Failure Trial. At its start in 1997, the trial was designed to enroll some 4000 patients in 300 centers worldwide.
Compared with placebo, Diovan achieved "significant reductions in morbidity and hospitalizations for heart failure in patients who already take therapy prescribed" for their condition, Novartis Pharmaceuticals said.
The researchers found that the rate of mortality was similarly low between groups, and the adverse events most commonly reported were dizziness and hypotension, according to the East Hanover, New Jersey-based firm.
Approval of Diovan as an adjunct to non-ACE inhibitor heart failure agents is predicated on the "further analysis of existing data or possibly the submission of additional data," the company noted.
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