FDA stiff arms No­var­tis in a sur­prise set­back for their PC­SK9 drug in­clisir­an

No­var­tis is not get­ting an ex­pect­ed ap­proval for in­clisir­an af­ter all. At least, not this year.

The phar­ma gi­ant an­nounced Fri­day evening that the agency has hand­ed out a CRL for the PC­SK9 drug from Al­ny­lam, which was wide­ly ex­pect­ed to get ap­proved and go on to shake up that seg­ment of the mar­ket.

Ac­cord­ing to No­var­tis, the FDA said it wasn’t able to hit their De­cem­ber 23rd PDU­FA date due to “un­re­solved fa­cil­i­ty in­spec­tion-re­lat­ed con­di­tions. The con­di­tions will be con­veyed to the Eu­ro­pean man­u­fac­tur­ing fa­cil­i­ty with­in 10 busi­ness days.”

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