Re­gen­eron ditch­es high­er dose of pain drug fas­inum­ab in PhI­II, trig­ger­ing safe­ty scare; In a small win for Al­ny­lam, FDA de­lays re­view for Ion­is' in­ot­ersen

→ Re­gen­eron $REGN has canned its high dose arm of fas­inum­ab, an os­teoarthri­tis and back pain drug be­ing test­ed in Phase III tri­als, fol­low­ing rec­om­men­da­tions from an in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee. A risk-ben­e­fit as­sess­ment was done on the high­er dose of the drug, and the com­mit­tee found it want­i­ng.

Re­gen­eron hasn’t yet re­leased any de­tails about the as­sess­ment, but this isn’t the first time fas­inum­ab has come un­der fire. In 2016, the FDA slapped a clin­i­cal hold on the com­pa­ny’s Phase IIb study of the drug in low­er back pain. The hold was trig­gered af­ter a pa­tient in the study suf­fer­ing from ad­vanced os­teoarthri­tis de­vel­oped a case of ad­ju­di­cat­ed arthropa­thy – joint dis­ease.

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