Novartis’ Tekturna faces three month delay

FDA extends its review of Novartis' NDA for its potential first-in-class oral rennin inhibitor Tekturna (aliskiren) by three months, the company announces Dec. 14. A delay was expected after Novartis said during its R&D day that it was submitting additional data to FDA about the antihypertensive's impact on the colon (1"The Pink Sheet" Dec. 11, 2005, p. 10). Novartis filed aliskiren for both single agent and combination treatment of high blood pressure in the first quarter, setting a late December user fee date. A review extension for Tekturna is the second regulatory setback for Novartis in recent months; the firm announced Nov. 13 that FDA extended the review period for the DPP-4 diabetes agent Galvus (vildagliptin) by three months to assess dermatologic toxicity (2"The Pink Sheet" Dec. 4, 2006, p. 9)...