Long side­lined on man­u­fac­tur­ing penal­ties, As­traZeneca fi­nal­ly gets a green light for a po­ten­tial hy­per­kalemia block­buster

Af­ter be­ing forced to the side­lines as Vi­for cleaned up its prob­lems with its hy­per­kalemia drug Veltas­sa and bur­nished hopes for big sales, As­traZeneca is fi­nal­ly in busi­ness and ready to take the field with a ri­val mar­ket­ing team.

The FDA has ap­proved As­traZeneca’s ri­val drug ZS-9, to be sold as Lokel­ma, af­ter twice spurn­ing the drug ap­pli­ca­tion due to man­u­fac­tur­ing is­sues.

That’s not what the phar­ma gi­ant had been think­ing when it snapped up the late-stage drug in the $2.7 bil­lion ZS Phar­ma buy­out three years ago. Its re­peat­ed set­backs at the agency un­der­scored the com­pa­ny’s fre­quent de­vel­op­ment prat­falls in re­cent years, par­tic­u­lar­ly out­side of the on­col­o­gy are­na. But the phar­ma heavy­weight now has a chance to re­deem it­self with an ag­gres­sive sales ef­fort as rev­enue from its main­stay fran­chise drug Crestor crum­bles in the face of gener­ic com­pe­ti­tion.

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