Roche's Genentech Inc. won US FDA approval on Nov. 16 for its once-weekly injection Hemlibra as a prophylactic treatment for adult and pediatric patients who have hemophilia A with inhibitors, which could free patients from multiple weekly infusions.
And at a cost that's at least half of the current prophylaxis treatment with potentially better efficacy and a safety concern that now looks manageable, uptake among prescribers, patients and payers could be strong. Hemlibra (emicizumab-kxwh, ACE910) is expected to be a blockbuster product, though peak sales estimates range from $1.1bn to $5bn
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