Novartis announced that it received FDA approval for

hypertension treatment Tekamlo, which combines the company's Tekturna (aliskiren) with amlodipine, as a first-line treatment for patients who are likely to need multiple drugs to achieve blood pressure goals and as a replacement therapy for patients whose hypertension is not adequately controlled by either drug alone.

The approval was based on clinical trial data from more than 5000 patients with mild-to-moderate hypertension that demonstrated that Tekamlo resulted in greater reductions in systolic and diastolic blood pressure compared to Tekturna or amlodipine alone. Two additional studies involving patients with moderate-to-severe high blood pressure achieved similar results.

In other news, the company announced it also received approval from Swiss regulators for Tasigna (nilotinib) as a first-line treatment for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase. The drug previously received approval in this indication from regulators in the US and Europe.

Commenting on the news, Helvea analyst, Karl-Heinz Koch said "with the step-back from immediately completing the last step of the Alcon transaction Novartis created the preconditions for the share price to recover," adding that "ample product news flow should also make Novartis shares more valuable." Analysts project a further share price recovery when the FDA makes a decision on the company's multiple sclerosis drug Gilenia (fingolimod), as well as from positive trial data on its kidney cancer drug Afinitor and macular oedema drug Lucentis. They note that an uptick in share price will likely appease Alcon's minority shareholders, who stand to receive 2.8 Novartis shares for one Alcon share as part of the acquisition offer

 

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