The first sign there may be trouble with Novartis' new drug application (NDA) for imatinib as a pulmonary arterial hypertension (PAH) treatment came on 15 August when the US FDA called off the 14 September meeting of its Cardiovascular and Renal Drugs Advisory Committee, although regulators declined to disclose the trigger for the cancellation.
Novartis spokeswoman Julie Masow, however, told Scrip the Swiss drug maker had decided to withdraw its NDA for the product, whose active ingredient already is marketed as Gleevec/Glivec for several cancer indications