EU Approves Roche's Actemra/RoActemra Against Severe Covid-19
December 07 2021 - 4:51AM
Dow Jones News
By Mauro Orru
The European Union approved a potential medicine developed by
Roche Holding AG to treat people with severe Covid-19.
The Swiss pharmaceutical major said Tuesday that the European
Commission, the EU's executive arm, had extended the marketing
authorisation for Actemra/RoActemra to include the treatment of
Covid-19 in adults who are receiving systemic corticosteroids and
require supplemental oxygen or mechanical ventilation.
"Actemra/RoActemra is the second Roche medicine to have received
rapid European Commission approval in Covid-19 in recent weeks,"
said Levi Garraway, Roche's chief medical officer and head of
global product development.
"The totality of evidence shows that Actemra/RoActemra can
benefit those suffering with severe Covid-19," Mr. Garraway
said.
The decision comes after the European Medicines Agency's
Committee for Medicinal Products for Human Use reviewed results
from four studies of the potential medicine in more than 5,500
patients with severe or critical Covid-19.
The World Health Organization has recommended Actemra/RoActemra
for the treatment of Covid-19, expecting the medicine to be
effective despite the emergence of the new Omicron variant.
The drug has also received provisional approval in Australia,
and is authorized for emergency use in the U.S. and Ghana.
Write to Mauro Orru at mauro.orru@wsj.com; @MauroOrru94
(END) Dow Jones Newswires
December 07, 2021 04:36 ET (09:36 GMT)
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