The COVID-19 pandemic created an unexpected boost for Roche when health facilities in China started snapping up its IL-6 inhibitor Actemra to treat dangerous complications in COVID-19 patients. Sales of the drug soared 30% in the first quarter of this year as the pandemic spread across the world.
Now, Roche is looking to boost Actemra’s profile in COVID-19 by launching a trial of the drug in combination with Gilead Sciences’ antiviral remdesivir, which was approved for emergency use May 1. Roche said Thursday it is collaborating with Gilead on a phase 3, 450-patient trial comparing remdesivir alone to a remdesivir-Actemra regimen in patients with severe COVID-19 pneumonia.
Even though Gilead has yet to fully launch remdesivir, the research community is already buzzing about the potential to combine the drug with other attack mechanisms against COVID-19. The National Institute of Allergy and Infectious Diseases recently started a trial combining the Gilead antiviral with Eli Lilly’s JAK inhibitor Olumiant, for example.
Actemra was originally approved by the FDA in 2010 to treat rheumatoid arthritis, but its potential in tamping down dangerous immune reactions came to the fore during the development of the two FDA-approved CAR-T treatments for cancer, Novartis’ Kymriah and Gilead’s Yescarta. In 2017, the FDA approved Actemra to treat cytokine release syndrome—a potentially deadly immune reaction—in cancer patients receiving CAR-T cells.
Still, that 30% first-quarter jump in Actemra sales was notable given the drug only saw an 8% sales boost in the same quarter a year before. To meet demand for Actemra, Roche has been ramping up production at its site in Vacaville, California, and elsewhere while simultaneously collecting data on the drug’s usefulness in COVID-19.
The Actemra-remdesivir combo trial is the latest in a string of COVID-19 initiatives Roche is pursuing. The company is also part of an accelerated vaccine-development program run by the National Institutes of Health.
Then there’s the diagnostics side of addressing the pandemic, where Roche is also a major player. In March, Roche won a speedy FDA approval of its COVID-19 test. Earlier this month, it scored a green light for its COVID-19 antibody test and vowed it would invest $459 million to ramp up manufacturing of the product at its site in Penzberg, Germany.
As for Gilead, it rolled out much-anticipated data on remdesivir’s effectiveness in COVID-19 late last week. In hospitalized patients who required oxygen, the drug cut recovery time by 47% over placebo, the data showed. The overall probability that patients taking remdesivir would improve clinically was 50% higher than it was among those on placebo.
Not bad, but some Wall Street analysts had bones to pick with the trial. Evercore ISI analyst Umer Raffat pointed out that the data didn’t answer the question of whether giving remdesivir early in the disease process cuts mortality rates. Gilead is running a separate study in moderately ill patients that is expected to produce data soon.