FDAnews
www.fdanews.com/articles/203355-roche-distributes-covid-19-antibody-for-treating-hospitalized-patients

Roche Distributes COVID-19 Antibody for Treating Hospitalized Patients

June 29, 2021

Roche said it will immediately begin shipping Actemra (tocilizumab) to hospitals after receiving emergency authorization from the FDA late last week.

Actemra’s authorization was supported by data from four studies with 5,500 participants, including one arm of the UK’s Recovery trial, which has reviewed multiple potential COVID-19 treatments. In that study, more than 4,000 hospitalized patients with severe COVID-19 pneumonia were randomized to receive either Actemra or usual care, with the Actemra cohort displaying a significant reduction in risk of death, 4.2 percent by day 28.

Roche appears well-prepared to mass produce the blockbuster drug for U.S. distribution, having entered into a manufacturing deal in April with Novartis to produce the drug’s active pharmaceutical ingredient.

Actemra earned almost $3.2 billion in global sales in 2020 and the new authorization as a COVID-19 treatment should lead to a significant increase in revenue for 2021.

View today's stories