FDA slaps down No­var­tis' block­buster pitch for canakinum­ab — so what went wrong?

In a ma­jor set­back, No­var­tis used its quar­ter­ly earn­ings re­port to flag an FDA slap­down on their ap­pli­ca­tion to mar­ket canakinum­ab for car­dio risk re­duc­tion.

Tout­ed as a block­buster in­di­ca­tion, the phar­ma gi­ant steered this drug through a big late-stage de­vel­op­ment pro­gram, even pulling out da­ta on a large sub­group of pa­tients that could ben­e­fit from the drug. The then de­vel­op­ment chief Vas Narasimhan was pro­mot­ed to CEO in part on the suc­cess he had with this drug — on­ly to get hit with a com­plete re­sponse let­ter.

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