FDA ex­pert pan­el lines up 19-to-1 against Pfiz­er’s os­teoarthri­tis drug tanezum­ab

Out­side ex­perts ad­vis­ing the FDA vot­ed 19 to 1 against Pfiz­er’s po­ten­tial os­teoarthri­tis drug tanezum­ab, say­ing the pro­posed risk eval­u­a­tion and mit­i­ga­tion strat­e­gy (REMS) will not en­sure the ben­e­fits of the drug out­weigh the risks. One of the two con­sumer reps vot­ed yes.

Two dif­fer­ent FDA ad­vi­so­ry com­mit­tees on arthri­tis and drug safe­ty came to­geth­er over the last day and a half to re­view Pfiz­er’s drug, with pan­elists rais­ing se­ri­ous con­cerns about the safe­ty of the drug and how ef­fec­tive it is.

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