Thursday, June 9, 2011

ACTOS - BLADDER CANCER - FDA also issues a warning on increased risk of bladder cancer associated with Actos


The probable implications are
1) Other country regulators will start looking at the actos with more caution and there are chances that Actos may meet Avandia kind of fate. (world wide withdrawal). The European Medicine agency will meet between 20th to 23rd June to decide on the fate of pioglitazone. Germany has already halted further sales of pioglitazone

2) Emerging treatment in diabetes will be the obvious beneficiaries ( DPP-IV's - Januvia,  SGLT-2 - Dapagliflozin and GLP-1 - Victoza and Byetta)

3) Indian companies - (Both API and formulation) which are marketing generic pioglitazone (Cipla, Lupin, Sun, iPCA, Indoco etc) will face some heat. This decision would also effect generic companies which plan to launch generic pioglitazone, as its patent is to expire shortly.