The medicine was already approved in the EU for treating inflammatory conditions rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis and cytokine release syndrome (CRS). The marketing authorisation has now been extended to include COVID-19 patients who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
Roche received Emergency Use Authorization for the monoclonal antibody against COVID-19 from the US Food and Drug Administration (FDA) in June; as well as from Australia's Therapeutic Goods Administration last week.
IL-6 receptor biologic
RoActemra is an immunomodulating medicine, designed to change immune system activity.
RoActemra attaches to the receptor for a messenger molecule or ‘cytokine’ called interleukin-6 (IL-6). IL-6 is produced by the body’s immune system in response to systemic inflammation, which plays an important role in severe COVID-19 disease and associated respiratory failure. By preventing IL-6 from attaching to its receptors, RoActemra reduces the inflammation and improves symptoms of severe COVID-19.
The European Medicines Agency’s human medicines committee (CHMP) evaluated data from 4,116 hospitalised adults with severe COVID-19 who required extra oxygen or mechanical ventilation and had high levels of C-reactive protein in the blood, indicating inflammation.
The study showed that treatment with RoActemra given by infusion in addition to standard treatment reduces the risk of death when compared with standard treatment alone.
Overall 31% of patients treated with RoActemra plus standard treatment (621 out of 2,022) died within 28 days of treatment compared with 35% of patients receiving standard treatment alone (729 out of 2,094). In addition, 57% of patients (1,150 out of 2,022) who received RoActemra were able to leave the hospital within 28 days compared with 50% of patients (1,044 out of 2,094) who received standard treatment alone.
'An important piece of the care puzzle'
Meanwhile, Roche’s Ronapreve (casirivimab and imdevimab; known as REGEN-COV in the US) was approved by the European Commission last month to treat non-hospitalised COVID-19 patients and for prophylaxis of the disease.
“Actemra/RoActemra is the second Roche medicine to have received rapid European Commission approval in COVID-19 in recent weeks,” said Levi Garraway, M.D., Ph.D., Roche’s CMO and head of global product development. “The totality of evidence shows that Actemra/RoActemra can benefit those suffering with severe COVID-19. Together with vaccines, other treatments and testing, Actemra/RoActemra forms an important piece of the care puzzle as we confront new challenges of the pandemic in Europe and around the world.”
Outside the EU, Actemra/RoActemra has been provisionally approved in Australia, authorised for emergency use in the US and Ghana, and recommended by the World Health Organization (WHO) for the treatment of COVID-19.
Following the emergence of the Omicron variant, the WHO has reported that interleukin 6 receptor blockers, such as Actemra/RoActemra, are expected to still be effective for managing patients with severe COVID-19.