Last checked at 
* Re-purposed anti-inflammation drug wins FDA emergency nod
* Revenue from Actemra's COVID-19 use has already spiked
* Studies of Actemra for COVID had successes, failures
(Adds background, comment from company)
June 24 (Reuters) - U.S. health regulators have approved
Roche's arthritis drug Actemra for emergency use to
treat hospitalized COVID-19 patients, giving an extra boost to a
medicine that was already allowed to be administered on
compassionate grounds.
The U.S. Food and Drug Administration (FDA) said on Thursday
it had issued an emergency use authorization (EUA) for Actemra
to treat adults and pediatric patients hospitalized with
COVID-19.
For months already, the medicine has been given to severely
ill COVID-19 patients on a compassionate-use basis, generating
hundreds of millions in sales for Roche.
The drug can be used to treat patients who are receiving
systemic corticosteroids and require supplemental oxygen,
non-invasive or invasive mechanical ventilation, or
extracorporeal membrane oxygenation, the FDA said, adding
studies showed Actemra helped reduce risk of death and speed
recovery.
The EUA is based on results from four randomized, controlled
studies that evaluated Actemra for the treatment of COVID-19 in
more than 5,500 hospitalized patients, Roche said.
In the first quarter, Actemra sales rose 22% to 779 million
Swiss francs ($850 million), after surging nearly a third to 2.9
billion francs in 2020, mostly due to treatment of patients with
severe COVID-19-associated pneumonia.
Though rising vaccinations in places such as Europe and the
United States are reducing hospitalizations for COVID-19,
Actemra is still being deployed for certain patients who land in
the hospital.
"Even with the availability of vaccines and declines in
deaths from COVID-19 in various parts of the world, we continue
to see new hospitalizations from severe forms of the disease,”
said Levi Garraway, the company's chief medical officer.
Testing Actemra for COVID-19 patients involved trial and
error, as successes in studies underpinning the FDA's EUA were
accompanied by several failures in different patient groups as
the Swiss company gathered knowledge about just who would
benefit.
Actemra is not authorized for use in outpatients with
COVID-19 or as a treatment for COVID-19, the health agency said.
Last year, the FDA approved Gilead Sciences Inc's
antiviral drug remdesivir for treating patients hospitalized
with COVID-19, but a trial mixing Actemra with remdesivir failed
to cut hospital stays.
($1 = 0.9170 Swiss francs)
(Reporting by Aishwarya Nair in Bengaluru and John Miller in
Zurich; Editing by Sherry Jacob-Phillips and Mark Potter)
