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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