Novartis (NVS) recently received a boost with the US Food and Drug Administration (FDA) approving Tekamlo for the treatment of high blood pressure. Tekamlo is a combination of Novartis’ Tekturna and amlodipine.
 
The FDA granted approval for the use of Tekamlo as an initial therapy in patients who might need several drugs to control their blood pressure. It is also approved for use as a replacement therapy in patients who have been using Tekturna or amlodipine without much success.
 
Approval was based on data collected from clinical studies involving more than 5,000 patients. Results from these studies showed that Tekamlo led to a major reduction in blood pressure compared to amlodipine or Tekturna alone.
 
Novartis already has a strong presence in the blood pressure market. According to estimates, approximately one billion people suffer from high blood pressure. The company has several products targeting this market including Diovan, Exforge, Tekturna and Lotrel. The approval of Tekamlo provides patients with a new treatment option. Moreover, being a single-pill combination, Tekamlo should be more convenient to use.
 
Novartis currently has a triple combination therapy in phase III development for the treatment of high blood pressure. This pill is a combination of amlodipine, Tekturna and a diuretic.
 
The approval and launch of new products should help drive sales of Novartis’ cardiovascular and metabolism segment. Sales from this segment came in at $8.8 billion in 2009, up 7% year over year. 
 
We currently have a Neutral recommendation on Novartis, which is supported by a Zacks Rank #3 (short-term “Hold” rating). The company has made significant progress with its pipeline. In addition to gaining approval for Tekamlo, Novartis’ pipeline recently gained a boost with the FDA approval of Tasigna for newly diagnosed chronic myeloid leukemia patients and a favorable recommendation from the FDA’s advisory panel regarding the approval of multiple sclerosis candidate, FTY720.
 
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