FDA ap­proves new type of heart fail­ure drug from drug­maker Am­gen


Pa­tients with chronic heart fail­ure, a dis­abling, deadly dis­ease that wors­ens as the heart grad­u­ally pumps less ef­fi­ciently, are get­ting a much-needed new op­tion with U.S. ap­proval Wed­nes­day of a novel drug from Am­gen Inc.

Cor­lanor is the first med­i­ca­tion in a dozen years for heart fail­ure, which is be­com­ing more com­mon with obe­sity — and more peo­ple sur­viv­ing heart at­tacks due to bet­ter treat­ments.

Mean­while, the Food and Drug Ad­min­is­tra­tion is re­view­ing an­other heart fail­ure pill, from No­var­tis AG, and could ap­prove it this sum­mer.

More than 5 mil­lion Amer­i­cans and more than 25 mil­lion peo­ple world­wide have heart fail­ure, which kills up to half of pa­tients within five years, de­spite nu­mer­ous generic pills and other treat­ments avail­able. It costs the global econ­omy an es­ti­mated US$108 bil­lion an­nu­ally, mostly for re­peated hos­pi­tal­iza­tions, so pre­vent­ing those is a key cost-con­trol tar­get.

For most pa­tients, it’s a chronic con­di­tion, caused by high blood pres­sure or other fac­tors dam­ag­ing heart mus­cle. That leaves many pa­tients with “low-ejec­tion frac­tion,” mean­ing the heart’s main pump­ing cham­ber can’t push out any­where near the 50 per­cent or more of blood a healthy heart ejects.

Symptoms in­clude breath­less­ness, fa­tigue and fluid re­ten­tion. That keeps many pa­tients home­bound and causes re­peated emer­gency depart­ment vis­its, of­ten in the mid­dle of the night, due to in­fec­tions or just stray­ing from a low-salt diet.

In pa­tient tests the drug­mak­ers funded, the new pills from Am­gen, of Thou­sand Oaks, Cal­i­for­nia, and Switzer­land’s No­var­tis, the world’s big­gest drug­maker by rev­enue, each made pa­tients feel bet­ter and sig­nif­i­cantly re­duced hos­pi­tal­iza­tions and deaths from heart fail­ure.

“Both drugs ben­e­fited pa­tients with ejec­tion frac­tion less than 35 per­cent,” said Dr. Mary Norine Walsh, an Amer­i­can Col­lege of Car­di­ol­ogy vice pres­i­dent who over­sees heart fail­ure treat­ment and car­diac trans­plan­ta­tion at St. Vin­cent Heart Cen­ter in In­di­anapo­lis.

She said doc­tors and pa­tients await the new medicines, which work dif­fer­ently and tar­get slightly dif­fer­ent pa­tient sub­groups, with some over­lap.

“The No. 1 thing is go­ing to be how ex­pen­sive” the drugs are and whether in­sur­ers set high co-pays — if they even cover them, Walsh stressed. “When we say to a pa­tient that we’ll re­place your medi- cine that you can get for US$4 (as a generic), non­med­i­cal de­ci­sion­mak­ing will come into play.”

Am­gen says Cor­lanor’s list price will be US$375 per month, with­out in­sur­ance. No­var­tis hasn’t set its drug’s price yet.

Af­ter Cor­lanor’s ap­proval was an­nounced late Wed­nes­day, its shares rose US$2.94, or 1.8 per­cent, to US$168.41 in af­ter-hours trad­ing. They rose US$2.90 in regular trad­ing.

The FDA, which gave Cor­lanor pri­or­ity re­view be­cause of the need for bet­ter heart fail­ure treat­ments, noted that women tak­ing it shouldn’t be­come preg­nant be­cause of risk of harm to a fe­tus.

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