China’s use of Roche's Actemra for some COVID-19 patients has put the arthritis drug in the spotlight and set it up for a surge in demand. Roche is trying to stay ahead of that curve by upping production, even as it tests it on COVID-19 for effectiveness.
The Swiss drugmaker today said that it is “working urgently to accelerate manufacturing capacity to maximize production of Actemra” when and where it can to boost its global supply.
It pointed out, however, that supply is managed on a country level and within parameters set by governments, so it is working closely with those regulators.
Roche is doing the same thing with its SARS-CoV-2 test, which has been tagged with an FDA Emergency Use Authorization for testing for COVID-19. At maximum production, Roche says it currently can supply millions of tests per month, but it is “working around the clock" to boost that number further.
While the drugmaker says it is doing everything within its means to pump up production, it is calling on governments to play nice to ease the path to patients by keeping borders open to international trade, easing regulations like packaging reviews and working together “in order to balance global needs.”
Roche started getting inquiries about Actemra from governments around the world after China’s National Health Commission added Actemra to its updated COVID-19 treatment guidelines in early March. Front-line doctors there had reported benefits for treating cytokine release syndrome in seriously and critically ill patients.
Roche, however, wants scientific proof, not just anecdotes, to support any use on COVID-19. It is working with the FDA to start a randomized, double-blind, placebo-controlled phase 3 clinical trial to study Actemra in hospitalized patients with severe COVID-19 pneumonia caused by the novel coronavirus. It expects to begin enrolling patients in the trial in early April. Several clinical trials testing Actemra in COVID-19 are already underway in China.