Roche has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for its subcutaneous formulation of RoACTEMRA (tocilizumab) to treat moderate to severe active rheumatoid arthritis (RA).
The treatment is intended for RA patients who have either responded inadequately to, or who are intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) inhibitors.
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If approved, RoACTEMRA would be the first humanised interleukin-6 (IL-6) receptor-antagonist biologic in subcutaneous and intravenous formulation for both monotherapy and combination therapy.
Roche head of global product development and chief medical officer Hal Barron said: "With the new RoACTEMRA subcutaneous formulation adult patients or their caregiver will be able to administer the medicine at home after appropriate training."
The positive opinion is based on data from the Phase III SUMMACTA and BREVACTA trials; SUMMACTA demonstrated that the efficacy and tolerability of subcutaneous RoACTEMRA was comparable with IV RoACTEMRA.
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The European Commission (EC) will now consider the CHMP positive opinion for its decision on the marketing authorisation for the subcutaneous formulation in the EU.
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By GlobalDataThe company said that the subcutaneous formulation is administered under the skin and would be available via a prefilled syringe and a prefilled pen, a medical device designed for self-administration of a single dose of drug.
Earlier this year, the subcutaneous formulation was authorised in Japan and the US under the name Actemra.
Across the world, an estimated 70 million people are affected with RA, which causes joints to become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged.
The RoACTEMRA clinical development programme comprises five Phase III clinical studies and has enrolled more than 4,000 people with RA in 41 countries.
In addition, the Phase IV ADACTA trial showed that monotherapy with RoACTEMRA IV was superior to monotherapy with adalimumab in reducing signs and symptoms of RA in MTX-intolerant patients or patients for whom MTX treatment was considered ineffective or inappropriate.
According to the company, the overall safety profile of both medications was consistent with previously reported data.
Image: X-ray of the hand in rheumatoid arthritis. Photo: courtesy of Braegel.
