Novartis Drug Gets FDA OK

The US Food and Drug Administration recently approved Novartis’ (NVS - Snapshot Report) Valturna for high blood pressure. The drug is a single-pill combination of Diovan (valsartan), an angiotensin receptor blocker, and Tekturna (aliskiren), the only approved direct renin inhibitor.

We believe the approval is quite significant as Diovan, one of Novartis’ top-selling drugs with global sales of $5.7 billion in 2008 is losing patent protection in most European Union countries in 2011 and in the U.S. in 2012. Competition is likely to intensify shortly as Merck’s (MRK - Analyst Report) Cozaar (2008 sales of $3.5 billion) will lose exclusivity in the U.S. in 2010, bringing in low-priced generics.

The approval was based on a randomized, double-blind, placebo-controlled clinical trial on 1800 patients. The trial studied the impact of valsartan (160 mg and 320 mg) and aliskiren (150 mg and 300 mg) independently as well as in a combination therapy. It was found that blood pressure reductions with the Valturna combination were significantly greater than with the individual drugs or placebo at the 8-week primary endpoint.

Valturna will become an important alternative treatment option where blood pressure is not adequately controlled by aliskiren or angiotensin receptor blocker monotherapy. Research suggests that up to 85% of patients with high blood pressure may need multiple medications to keep their blood pressure in check, which further emphasizes the need for a combination treatment. The drug can be used for initial therapy as well for the patients who need multiple drugs.

Globally, more than a billion people are affected by high blood pressure, which is the prime cause of death worldwide. If left untreated, patients with high blood pressure are at risk of cardiovascular malfunctioning such as stroke, heart attack and heart failure, and of organ damage including kidney failure and vision problems. We believe Valturna should further strengthen the cardiovascular portfolio of Novartis, which recorded sales of $6.7 billion in 2008.