FDA OKs CSL’s new HAE drug, al­ready em­broiled in a block­buster fight with Shire

CSL Behring’s Bern, Switzer­land man­u­fac­tur­ing cam­pus

CSL Behring has picked up an FDA OK to start mar­ket­ing its new drug for rare cas­es of hered­i­tary an­gioede­ma, which is al­ready em­broiled in a court fight trig­gered by its HAE ri­vals at Shire. And in do­ing so, the FDA has now crossed the line for all its new drug ap­provals of 2016, still just shy of the halfway mark to the year.

The agency’s ap­proval for the C1 es­terase in­hibitor Hae­gar­da came through Thurs­day evening, two months af­ter Shire fired a pre­emp­tive le­gal shot in US Dis­trict Court in Delaware claim­ing that CSL’s drug vi­o­lates its new patent for its own C1 drug Cin­ryze. Shire — which saw its shares $SH­PG drop 1.3% Fri­day morn­ing — al­so mar­kets Fi­razyr and Kalbitor for HAE, a fran­chise that CSL hopes to carve up with a drug that can be self-ad­min­is­tered.

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