J&J's Simponi Launch Spoiled by FDA Letter Warning of Fatal Fungus Infections

Johnson & Johnson’s Simponi, its successor to Remicade, is off to a bad start: The FDA issued a “Dear Doctor” letter noting that it might kill you if your doc doesn’t know what he’s doing. “Serious fungal infections” are associated with Simponi, the letter states, and if they go unrecognized it can result in death.

Simponi, made by J&J’s Centocor Ortho Biotech unit, was approved in April. The letter states:

… invasive fungal infections are not consistently recognized in patients taking other TNF-a blockers including Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). This has resulted in delays in appropriate antifungal treatment, sometimes even resulting in death.

J&J will find the FDA’s letter particularly annoying because although it comes on the heels of Simponi’s launch, it actually applies to all tumor necrosis factor blockers. While that will allow J&J to claim Simponi is not uniquely dangerous, it logically follows that Simponi is therefore pretty much like all its competitors when it comes to fungus.

Differentiating between these drugs is a serious business. As Amgen found out in a recent Enbrel lawsuit, patients can develop strong fears of certain brands, particularly if they believe that competing brands offer an advantage.

And while the letter is not likely to affect the arbitration over the revenue-sharing agreement between J&J and Merck/Schering-Plough for Remicade and Simponi, any new wrinkle around those drugs before that pact is sorted out will be carefully watched.

Separately: It didn’t take long for these vultures to begin circling.