Nice Endpoints News article by John Carroll on the FDA "slapdown" of Novartis' Canakinumab application. Seems that Novartis was wanting to market based on sub-group data and the FDA was not on board with that. John Carroll cites an analyst in his article stating that patent protection on canikinumab may run out in ~7 years. An opportunity for Resverlogix and Apabetalone to steal the spotlight on the inflammation hypothesis? Let's just hope that Resverlogix can learn from this Novartis/FDA incident in the case that Resverlogix plans to market based on BETonMACE sub-group analyses.
FDA slaps down Novartis’ blockbuster pitch for canakinumab — so what went wrong?