FDA lets Lilly cite Jar­diance heart data, shares jump

Kuwait Times - - HEALTH & SCIENCE -

WASH­ING­TON: US reg­u­la­tors said on Fri­day they would al­low Eli Lilly and Co to state that its di­a­betes drug Jar­diance re­duces risk of death from heart prob­lems, lift­ing com­pany shares al­most 3 per­cent and po­ten­tially giv­ing a strong boost to the drug’s fu­ture sales.

Jar­diance, a once-daily pill also known as em­pagliflozin, was ap­proved by the FDA in 2014 to help lower blood sugar in pa­tients with type 2 di­a­betes. It gen­er­ated global sales of $48 mil­lion in the third quar­ter.

Lilly sells the drug in part­ner­ship with pri­vately held Ger­man drug­maker Boehringer In­gel­heim. At the time of ap­proval the FDA asked that a sep­a­rate trial be con­ducted to show the drug did not in­crease the risk of car­dio­vas­cu­lar prob­lems.

The study in­stead un­ex­pect­edly showed Jar­diance slashed deaths by 32 per­cent in pa­tients with type 2 di­a­betes at risk of heart at­tack and stroke, when added to stan­dard di­a­betes med­i­ca­tions. It was the first time any di­a­betes drug was shown to re­duce risk of car­dio­vas­cu­lar death. More­over, pa­tients tak­ing Jar­diance had a 35 per­cent lower rate of hos­pi­tal­iza­tion for heart fail­ure. That in­for­ma­tion can now be in­cluded on the drug’s la­bel.

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