Coronavirus tracker: FiercePharma
In May, Roche kicked off its Evaluating Minority Patients with Actemra (EMPACTA) trial to study the arthritis med in underserved patients hospitalized with COVID-19 pneumonia.
Roche told Fierce Pharma that it aims to enroll around 375 patients globally in the phase 3 trial.
The study first launched via its Genentech unit in the U.S. and recently expanded to other countries, including South Africa, Kenya, Brazil, Mexico and Peru.
Roche’s Actemra falls short in Italian study in early-stage COVID-19 pneumonia
Jun 18, 2020 10:40am
Roche’s Actemra, one of several anti-inflammatory drugs in testing against coronavirus, didn’t help patients with early-stage COVID-19 pneumonia,
an Italian study found, though it might still prove useful for more advanced cases.
In a study authorized by Aifa,
Italy’s drug regulator,
Actemra didn’t improve patients’ severe respiratory symptoms, reduce ICU visits or cut mortality rates better than standard care.
Aifa said the study was the first randomized test worldwide for Actemra in COVID-19.
The study should be considered “important and conclusive” in early-stage COVID-19 pneumonia, Aifa said.
And it’s another challenge to the theory that IL-6 inhibitors, including Actemra and Sanofi and Regeneron’s Kevzara, can help treat coronavirus patients.
But for patients with severe COVID-19 pneumonia, other tests are ongoing.
Roche’s Genentech unit is running one trial that will “provide robust evidence about the benefit risk profile”
a spokeswoman told FiercePharma.
Roche is also testing the drug, approved to treat rheumatoid arthritis, in combo with Gilead Sciences’ remdesivir in severe COVID-19 pneumonia.
And it’s ramping up manufacturing to turn out more doses and build U.S.-based supply.
FiercePharma