Alk­er­mes adds bipo­lar I dis­or­der to its FDA wish­list; Con­go con­firms first Ebo­la case in large city

An ever-am­bi­tious Alk­er­mes $ALKS team plans to add bipo­lar I dis­or­der to its list of con­di­tions for ALKS-3831, which it plans to pitch to the FDA in Q4. Alk­er­mes says they were per­suad­ed to add bipo­lar I dis­or­der af­ter a pre-NDA meet­ing with the agency, which came about 7 months af­ter the biotech re­port­ed pos­i­tive da­ta for schiz­o­phre­nia. The drug is a com­bo us­ing olan­za­p­ine/sami­dor­phan, which they hope will be shown to be as ef­fec­tive as olan­za­p­ine with­out the sub­stan­tial in­crease in the risk of weight gain.

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