Roche Gains EU Approval for New Subcutaneous Formulation of RoActemra

The European Commission has approved the subcutaneous formulation of RoActemra (tocilizumab) for the treatment of moderate to severe rheumatoid arthritis (RA), drugmaker Roche said.

RoActemra is designed for patients who have proven intolerant or have failed to respond to other previous therapy using disease modifying anti-rheumatic drugs. The drug becomes the first anti IL-6 receptor biologic available in subcutaneous and intravenous formulations, Roche said.

The two formulas will give patients options for their treatment. “Together with their physicians, patients can choose whether to self-inject RoActemra at home or have it administered in their doctor’s office,” said Dr. Sandra Horning, Roche’s Chief Medical Officer and head of global product development.

The approval was based on data from an extensive development program that included five phase III clinical studies that enrolled more than 4,000 people with RA across 41 countries.

Studies showed that the efficacy and tolerability of subcutaneous RoActemra was comparable to that of the intravenous version, Roche said. They said studies also demonstrated long-term efficacy and reduced the advancement of RA-caused joint damage over 48 weeks.

RA affects more than 40 million worldwide. It causes chronic inflammation in joints, and patients can become increasingly disabled as cartilage and bone are damaged. — Kellen Owings

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