Madrigal reports new safety data for NASH candidate resmetirom weeks ahead of PDUFA date

Madri­gal has lift­ed the cur­tain on ad­di­tion­al late-stage safe­ty re­sults for its non­al­co­holic steato­hep­ati­tis (NASH) drug resme­tirom, with an­a­lysts ex­press­ing over­all op­ti­mism on the loom­ing FDA ap­proval de­ci­sion.

On the can­di­date’s safe­ty, resme­tirom’s mech­a­nism meant it could the­o­ret­i­cal­ly sup­press the se­cre­tion of pi­tu­itary thy­rotropin, which could in turn “pro­mote a hy­pothy­roid state in tis­sues not tar­get­ed by the agent,” Ken­neth Cusi, chief of en­docrinol­o­gy, di­a­betes and me­tab­o­lism at the Uni­ver­si­ty of Flori­da, said in an ed­i­to­r­i­al pub­lished on the in the New Eng­land Jour­nal of Med­i­cine. Resme­tirom is a thy­roid hor­mone re­cep­tor-be­ta ag­o­nist.

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