Unencumbered by safety concerns, Roche's Hemlibra gets breakthrough status for new patient group
Recent safety concerns have not stopped Roche from obtaining a speedy FDA review for using Hemlibra to treat hemophilia A patients without factor VIII inhibitors, a market segment crucial to Roche’s blockbuster quest for its new therapy approved last November.
Roche rattled the market when it reported five deaths among patients taking Hemlibra, including two that emerged earlier this year (The company emphasized that all five were unrelated to the drug). Jefferies analyst David Steinberg pointed out that heightened concerns could impact use in “non-inhibitor patients who are generally well controlled” on Advate, a factor replacement therapy from chief rival Shire.
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