In blow to Shire, Roche bags an FDA OK for its blockbuster hemophilia A prospect
Despite being dogged by questions about safety and an unusual legal counterattack from rival Shire, Roche today scored an FDA approval for emicizumab (ACE910), its hemophilia A therapy which will now hit the market as Hemlibra.
The drug is designed to bring together factor IXa and factor X proteins to restore the blood clotting process for hemophilia A patients, reducing the threat of bleeds. And analysts have pegged potential sales at up to $5 billion, though Reuters‘ most recent consensus was a considerably less frothy $1.6 billion.
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