Af­ter NIH tri­al, EMA be­gins rolling re­view for remde­sivir, set­ting up po­ten­tial au­tho­riza­tions in US and Eu­rope

A day af­ter the NIH re­leased pos­i­tive re­sults from their tri­al test­ing remde­sivir in Covid-19, the EMA has an­nounced the start of a rolling re­view process for the drug. With an FDA de­ci­sion ex­pect­ed to ar­rive in the com­ing days, the news sets the stage for the Gilead an­tivi­ral to be­come the stan­dard-of-care for the dead­ly virus in both the US and Eu­rope.

Yes­ter­day morn­ing, Gilead is­sued a press re­lease that the NIH would soon is­sue pos­i­tive da­ta on a much-an­tic­i­pat­ed tri­al test­ing their an­tivi­ral remde­sivir against a place­bo in Covid-19 pa­tients. The news prompt­ed im­me­di­ate spec­u­la­tion of whether an emer­gency use au­tho­riza­tion (EUA) — a clear­ance from the FDA that by­pass­es the lengthy ap­proval process — would fol­low. The agency had con­tro­ver­sial­ly is­sued an EUA for the an­ti­malar­i­als hy­drox­y­chloro­quine and chloro­quine in March, a de­ci­sion that was tak­en with­out the sup­port of a ran­dom­ized con­trolled tri­al.

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