Another Potential Blockbuster Drug namely Bardoxolone ( refer this article published earlier: http://www.pharmablockbusters.info/2011/12/bardoxolone-potential-mega-blockbuster.html ) felt the axe as it failed to clear the Ph III Clinical trials due to concerns about death and "excess serious adverse events" in patients taking the first-in-class antioxidant inflammation mediator (AIM).Bardoxolone was being developed in late-stage clinical trials by Reata Pharmaceuticals for the treatment of moderate to severe chronic kidney disease (CKD) in Type-2 Diabetes patients. The failure was a huge setback for Abbott Pharma which had paid Reata Inc. $450 million, plus milestone payments, in 2010, to license Bardoxolone for sales outside the U.S and Asia. It was to be one of the major products for the newly formed AbbVie Pharma* (split from Abbott Pharmaceuticals recently) along with arthritis blockbuster Humira (Adalimumab).
Bardoxolone was originally seen as a promising cancer dug. but in one of its cancer studies, researchers saw a big improvement in renal function among all renal cancer patients. Arrested progression of CKD or recovered kidney function was a provocative finding, and Reata pushed ahead with two Ph IIa trials for CKD in 2008, which produced positive results.
Some doctors involved in the trials believed that the trial's design had been a mistake from the outset, and that bardoxolone's potential side-effects could accelerate kidney disease.
The future seems uncertain for other AIMs (antioxidant inflammation mediators) as Bardoxolone joins the long list of Ph III failures after a promising start.
*On more information on AbbVie spinoff, visit: http://www.pmlive.com/pharma_news/abbott_completes_split_as_abbvie_debuts_on_nyse_457376
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