Roche's Genentech unit announced Monday that the FDA has authorised a Phase III trial in collaboration with the US Biomedical Advanced Research and Development Authority (BARDA) to evaluate intravenous Actemra (tocilizumab) plus standard care in adults hospitalised with severe COVID-19 pneumonia. The news comes shortly after the drugmaker said it would initiate testing of the anti-IL-6 receptor biologic, also known as RoActemra, in this setting.
In addition, Roche said it would provide 10,000 vials of Actemra to the US Strategic National Stockpile for potential future use, noting it has "robust business continuity and mitigation strategies in place, and current US supply of Actemra for approved indications is not expected to be impacted." The company indicated that it has also been working with distributors to manage product supply.
Alexander Hardy, chief executive officer of Genentech, thanked the FDA "for rapidly expediting the approval of this clinical trial," adding that "we're moving forward to enroll as quickly as possible." The COVACTA study is expected to recruit around 330 patients globally, starting in early April, with the primary and secondary endpoints assessing clinical status, mortality, mechanical ventilation and intensive care unit variables. Roche noted that while there are several clinical trials already underway around the world exploring the efficacy of Actemra for the treatment of patients with COVID-19 pneumonia, COVACTA "is vital because there are no well-controlled studies and limited published evidence" for the drug's use in treating patients with the novel coronavirus infection.
Actemra is currently cleared in the US for certain adult patients with moderately to severely active rheumatoid arthritis, as well as those two years and older with active polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, or CAR T cell-induced cytokine release syndrome.
Last week, Sanofi and Regeneron Pharmaceuticals initiated a clinical programme evaluating whether IL-6 inhibition with Kevzara (sarilumab) is better than current supportive care alone for patients hospitalised with severe COVID-19.
For a look at other therapies being investigated to fight the pandemic, see ViewPoints: Initial glimmers of hope for COVID-19 therapeutics.
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