Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

It's a year late, but No­var­tis has fi­nal­ly steered in­clisir­an to FDA ap­proval. Will it sell?

The cen­ter­piece of No­var­tis’s $9.7 bil­lion buy­out of the Med­i­cines Com­pa­ny can fi­nal­ly go to mar­ket.

Brand­ed Leqvio, the small in­ter­fer­ing RNA ther­a­py long known as in­clisir­an is the first and on­ly FDA-ap­proved treat­ment to re­duce LDL-C, i.e. bad cho­les­terol, with just two main­te­nance dos­es a year af­ter an ini­tial dose and an­oth­er one at three months.

Tout­ing a “rev­o­lu­tion­ary ap­proach,” No­var­tis CEO Vas Narasimhan not­ed that the ap­proval “cre­ates new pos­si­bil­i­ties for how health­care sys­tems can im­pact car­dio­vas­cu­lar dis­ease, a defin­ing pub­lic health chal­lenge of our time.” The la­bel cov­ers both ath­er­o­scle­rot­ic car­dio­vas­cu­lar dis­ease and het­erozy­gous fa­mil­ial hy­per­c­ho­les­terolemia.

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