Evoke Phar­ma fi­nal­ly lands ap­proval for lead and on­ly drug

Over a year af­ter the FDA first re­buffed Evoke’s ap­pli­ca­tion, the agency has ap­proved the small biotech’s lone drug, a treat­ment for a com­mon gas­troin­testi­nal com­pli­ca­tion of di­a­betes.

The drug, known as Gi­moti, is a nasal spray for treat­ing di­a­bet­ic gas­tro­pare­sis, a dis­or­der in which the mus­cles in the stom­ach can’t prop­er­ly clear food. In a Phase III study in 2016, the drug ac­tu­al­ly missed its pri­ma­ry end­point but showed a “clin­i­cal­ly mean­ing­ful ben­e­fit” in 51% of pa­tients with mod­er­ate to se­vere symp­toms at the out­set.

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