Roche
hemophilia drug wins fast-track FDA designation
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[September 04, 2015] ZURICH
(Reuters) - Roche said on Friday it had won breakthrough therapy
designation from the U.S. Food and Drug Administration for an
experimental hemophilia medicine, aiming for a piece of the $11 billion
hemophilia drug market.
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The Swiss drugmaker said its U.S.-based Genentech unit's ACE910
secured the fast-track designation as the company prepares separate
Phase III trials in 2015 and 2016, the first in patients with
hemophilia A with factor VIII inhibitors and the second for patients
without inhibitors.
It represents a threat to more traditional treatments from Novo
Nordisk and Baxalta, the target of a $30 billion takeover attempt by
Shire.
Hemophilia A is a rare genetic disorder that prevents blood
clotting. Patients receive lifesaving infusions of clotting factors,
but development of inhibitors in many of those being treated
interferes with efforts to control their bleeding.
With the market for hemophilia medications expected to grow to $11
billion next year, Roche's ACE910 drug is closely watched because it
could change the way the disease is treated.
"FDA has granted breakthrough therapy designation for ACE910,
recognizing an unmet need for patients with inhibitors and the
promise of these early data," Sandra Hornung, Roche's chief medical
officer, said in a statement.
Last year, Roche said early data indicated encouraging reduction in
bleeding rates in all patients.
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In 2012, U.S. regulatory changes created the breakthrough therapy
designation, allowing the FDA to expedite development and review of
drugs whose preliminary clinical evidence indicates substantial
improvement over existing therapies.
(Reporting by John Miller. Editing by Jane Merriman)
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