FDA eyes Am­gen choles­terol drug

Los Angeles Times - - TECHNOLOGY -

Fed­eral health reg­u­la­tors said Mon­day that a highly an­tic­i­pated ex­per­i­men­tal drug from Am­gen Inc. sig­nif­i­cantly low­ers bad choles­terol. But of­fi­cials have ques­tions about who should take the drug and whether to ap­prove it based on cur­rently avail­able data.

The Food and Drug Ad­min­is­tra­tion posted its re­view of Am­gen’s Repatha ahead of a public meet­ing to con­sider its ap­proval. Repatha is part of a new class of in­jectable, choles­terol-low- er­ing drugs that work dif­fer­ently from older statin drugs. The new drugs are con­sid­ered the first ma­jor ad­vance in low­er­ing bad, or LDL, choles­terol in more than 20 years, and an­a­lysts ex­pect them to gen­er­ate bil­lions of dol­lars in sales.

But the prospect of ap­prov­ing pricey new in­jectable drugs for one of the most com­mon med­i­cal con­di­tions in Amer­ica is al­ready drawing con­cerns from health in­sur­ers, providers and phar­macy benefits man­agers.

More than 73 mil­lion U.S. adults, or nearly one-third, have high LDL choles­terol, ac­cord­ing to the Cen­ters for Dis­ease Con­trol and Pre­ven­tion. Those pa­tients have twice the risk of heart dis­ease.

The FDA is con­sid­er­ing which pa­tients should re­ceive a pre­scrip­tion for drugs like Repatha.

Am­gen, based in Thou­sand Oaks, stud­ied the drug in sev­eral dif­fer­ent pa­tient groups, in­clud­ing those al­ready tak­ing statins, those who can­not take statins be­cause of side ef­fects and pa­tients with a rare ge­netic dis­or­der that causes ex­tremely high choles­terol lev­els.

On Wed­nes­day the FDA will ask a panel of out­side ex­perts which pa­tients are most likely to ben­e­fit from the drug, con­sid­er­ing po­ten­tial risks seen in stud­ies, in­clud­ing higher rates of pan­cre­ati­tis and kid­ney prob­lems. The same panel of ex­perts will re­view a sim­i­lar drug from Sanofi on Tues­day.

Both drugs block a sub­stance called PCSK9, which in­ter­feres with the liver’s abil­ity to re­move choles­terol from the blood.

Shares of Am­gen fell 78 cents, or 0.5%, to $156.47 on Mon­day.

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