Panel sup­ports Am­gen drug

FDA ad­vi­sors say the choles­terol-low­er­ing med­i­ca­tion should be al­lowed in some cases.

Los Angeles Times - - REAL ESTATE -

Fed­eral health ad­vi­sors said Wed­nes­day that a highly an­tic­i­pated choles­terol-low­er­ing drug from Am­gen Inc. should be ap­proved for pa­tients with dan­ger­ously high lev­els of the artery-clog­ging sub­stance.

But as with their re­view of a sim­i­lar drug a day ear­lier, the Food and Drug Ad­min­is­tra­tion ex­perts noted that long-term re­sults are needed to judge the drug’s real ben­e­fit.

The FDA ad­vi­sory panel voted 11 to 4 that Am­gen’s in­jectable drug Repatha ap­pears safe and ef­fec­tive for some pa­tients at high risk from choles­terol, par­tic­u­larly those with in­her­ited con­di­tions that cause choles­terol buildup. The FDA is not re­quired to fol­low the group’s ad­vice, though it of­ten does.

The en­dorse­ment came de­spite pending study re­sults on whether Repatha ul­ti­mately low­ers rates of heart attack and death. Re­sults from an Am­gen study on that ques­tion aren’t ex­pected un­til 2017.

Repatha is part of a new class of biotech drugs that low­ers choles­terol more than older statin med­i­ca­tions, which have been the stan­dard treat­ment for more than 20 years. Thou­sand Oaks-based Am­gen is rac­ing ri­vals Sanofi and Re­gen­eron, which re­ceived a pos­i­tive vote Tues­day for their drug, Pralu­ent.

Both Pralu­ent and Repatha lower low-den­sity lipopro­tein, or LDL, choles­terol more pow­er­fully and in a dif­fer­ent way from statins. They block a sub­stance called PCSK9, which in­ter­feres with the liver’s abil­ity to re­move choles­terol from the blood. Adding the new drugs to older statins has been shown to re­duce LDL, or “bad,” choles­terol, from 40% to 60%. Statins alone gen­er­ally lower lev­els of the wax-like sub­stance about 30% to 50%.

The prospect of ap­prov­ing a pricey new class of drugs for one of the most com­mon med­i­cal con­di­tions in the U.S. is al­ready drawing con­cerns from health in­sur­ers, em­ploy­ers and other pay­ers who would ab­sorb the costs.

More than 73 mil­lion U.S. adults have high LDL choles­terol, ac­cord­ing to the Cen­ters for Dis­ease Con­trol and Pre­ven­tion.

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