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 Hospital patients taking the drug were 44% less likely to need
ventilators or die, the company said, citing the results of its
Empacta phase III study conducted in several countries including the
United States.
Roche said it would share the results of its trial with health
authorities, including the U.S. Food and Drug Administration.
The news is a boost for Roche after an attempt to retool the
rheumatoid arthritis drug Actemra/RoActemra to treat patients
hospitalised with severe COVID-19 related pneumonia failed in a
late-stage trial.
Its Covacta trial did not meet its primary end-point of improved
clinical status in patients with COVID-19 associated pneumonia, or
the key secondary end-point of reduced patient mortality, the
company said in July.
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"The EMPACTA trial demonstrated that Actemra/RoActemra can reduce the need for
mechanical ventilation in patients with COVID-19 associated pneumonia, an
important outcome in this serious disease," said Levi Garraway, Roche's chief
medical officer and head of global product development.
The study is the first global phase III COVID-19 clinical trial using patients
from minority racial and ethnic groups, Roche said, adding this group are often
underrepresented in clinical studies and have been disproportionately affected
by the COVID-19 pandemic.
The majority were Hispanic, along with significant representation from black and
native American populations, the company said.
(Reporting by John Revill; Editing by Thomas Seythal and Christopher Cushing)
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