With patent con­cerns loom­ing, Roche gets a new pri­or­i­ty re­view on block­buster IPF drug

Sev­en years af­ter the FDA first ap­proved Es­bri­et, the block­buster Roche IPF drug is get­ting an ex­pe­dit­ed re­view for a sec­ond in­di­ca­tion.

On Thurs­day, the agency gave Es­bri­et pri­or­i­ty re­view for un­clas­si­fied in­ter­sti­tial lung dis­eases, or forms of pul­monary in­flam­ma­tion and scar­ring that don’t fit eas­i­ly in­to the over 200 known types of ILD. The move comes 10 months af­ter Es­bri­et re­ceived break­through des­ig­na­tion and sets Roche up for a de­ci­sion by May.

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