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 Roche is hoping to win a slice of the $11 billion-a-year haemophilia
drug market with the drug, also known as ACE910, which represents a
threat to more traditional treatments from Novo Nordisk and Shire.
Roche's drug is being closely watched because it could change the
way the disease is treated.
"The study showed a statistically significant reduction in the
number of bleeds over time in people treated with emicizumab
prophylaxis compared to those receiving no prophylactic treatment,"
Roche said in a statement.
The trial also met all secondary endpoints, including reducing the
number of bleeds over time with emicizumab prophylaxis treatment in
an intra-patient comparison in people who had received prior
bypassing agent prophylaxis treatment.
The most common adverse events were injection site reactions,
consistent with prior studies, it added.
Prospects for the potential blockbuster product were clouded when
news emerged last month that four patients suffered serious adverse
events in a clinical trial of the drug.
The problems related to thrombosis, or blood clots, with two
thromboembolic events and two cases of thrombotic microangiopathy (TMA)
in patients who were being treated for breakthrough bleeding in a
trial of ACE910.
Roche said at the time that additional monitoring had been
instigated and the cases involved patients with breakthrough
bleeding who were treated using one of two so-called bypassing
agents that carried thrombosis warnings.
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"Neither thromboembolic event required anti-coagulation therapy and
one patient restarted emicizumab. Both cases of TMA have completely
resolved, and one patient restarted emicizumab," Roche said on
Thursday.
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.
(Reporting by Michael Shields)
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