Still hunt­ing a block­buster, Mer­ck KGaA scores a win in the FDA ap­proval col­umn — more than 13 years in the mak­ing

Thir­teen years af­ter it was put on the FDA’s fast track, and 8 years af­ter the agency spurned it in a di­rect re­buke for an in­ad­e­quate late-stage de­vel­op­ment pro­gram, Mer­ck KGaA’s mul­ti­ple scle­ro­sis drug cladrib­ine is fi­nal­ly mak­ing its US de­but. The agency OK’d the oral drug on Fri­day for pa­tients who had failed at least 1 drug.

Tout­ed by Mer­ck KGaA health­care chief Be­len Gar­i­jo as a po­ten­tial block­buster, the EMA OK’d this drug last fall. It is be­ing mar­ket­ed un­der the brand name Maven­clad.

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