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Novartis seeks approval of imatinib for PAH

April 25, 2012 1:04 AM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) submitted regulatory applications in the U.S., EU and Japan for imatinib to treat pulmonary arterial hypertension. Imatinib is approved as Glivec in the EU and Gleevec in the U.S. for several cancer indications. Novartis made the announcement along with its 1Q12 financial results. Sales of the BCR-ABL tyrosine kinase inhibitor rose 6% to $1.1 billion in 1Q12.

On the clinical front, the pharma said it stopped a Phase III trial of pasireotide ( SOM230) in refractory/resistant carcinoid syndrome based on a futility analysis showing it was unlikely to meet the study's primary efficacy endpoint. In January, EMA's CHMP issued a positive opinion recommending approval of Signifor pasireotide for Cushing's disease. Novartis also discontinued development of sotrastaurin ( AEB071) to prevent kidney and liver transplant rejection and to treat psoriasis after Phase II results did not show sufficient therapeutic benefit over standard of care. AEB071 is an oral protein kinase C (PKC) inhibitor. Details were not disclosed. ...