FDA of­fers As­traZeneca a short­cut on a land­mark SGLT2 ap­proval while Chi­na green­lights Lokel­ma

The FDA may have snubbed As­traZeneca in its quest to ex­pand the ap­proval of its SGLT2 di­a­betes drug to type 1 pa­tients, but reg­u­la­tors are rolling out the red car­pet for an­oth­er big add-on in ap­provals.

Fol­low­ing some im­pres­sive da­ta demon­strat­ing Farx­i­ga’s abil­i­ty to cut the risk of death or heart fail­ure among pa­tients suf­fer­ing from re­duced ejec­tion frac­tion (HFrEF), they’ve giv­en the phar­ma gi­ant a pri­or­i­ty re­view for pa­tients with and with­out type 2 di­a­betes. And now it’s on track for a Q2 de­ci­sion and po­ten­tial near term roll­out in the car­dio mega-mar­ket.

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