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.
"There are currently no approved medicines for COVID-19 pneumonia," Genentech's spokeswoman said. "The fact that many companies and institutions are now working together to fight this complex disease will hopefully increase the collective scientific understanding of COVID-19 and translate to more options for patients."
Back in March, China’s National Health Commission added Actemra to its treatment guidelines after front-line physicians reported positive outcomes in using the drug to control lung inflammation in severe COVID-19 cases.
That led to a surge of interest, and throughout the pandemic response, investigators have started a range of studies for anti-inflammatory medicines. In April, though, Kevzara disappointed in a phase 2 trial in severe COVID-19 patients. The drug is now in late-stage testing in those who are critically ill.
Meanwhile, Genentech is in the process of building an “end-to-end" Actemra supply chain in the U.S., CEO Alexander Hardy said during a PhRMA webinar this week. Right now, the drug is produced in Europe. Genentech is making millions of doses in response to COVID-19, whereas previously the company produced doses in the hundreds of thousands.