events in trial dent hopes for Roche hemophilia drug
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[November 03, 2016]
LONDON (Reuters) - Four patients
have suffered serious adverse events in a clinical trial of an
experimental hemophilia medicine from Roche, the Swiss group said on
Wednesday, clouding prospects for its potential blockbuster product.
The problems relate to thrombosis, or blood clots, with two
thromboembolic events and two cases of thrombotic microangiopathy in
patients who were being treated for breakthrough bleeding in the
trial of Roche's ACE910.
Roche said additional monitoring had now been instigated in the
The drugmaker is hoping to win a slice of the $11 billion-a-year
hemophilia drug market with ACE910, which represents a threat to
more traditional treatments from Novo Nordisk and Shire.
Deutsche Bank analyst Richard Parkes said the problems suggested
that patients were still experiencing breakthrough bleeds despite
getting ACE910, cutting the chance that ACE910 was so effective as
to abrogate all bleeding risk.
"We view the news as the first blemish on ACE910's profile," he
A Roche spokesman said the cases involved patients with breakthrough
bleeding who were treated using one of two so-called bypassing
agents. He added that both agents -- Shire's FEIBA and Novo's
NovoSeven -- carried thrombosis warnings.
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Haemophilia patients, whose blood does not clot properly, need
life-saving infusions of clotting factors, but development of
inhibitors in many of those being treated can interfere with efforts
to control their bleeding.
Roche's ACE910, also known as emicizumab, is being closely watched
because it could change the way the disease is treated.
(Reporting by Ben Hirschler; Editing by Alexander Smith)
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