Roche and Chugai’s new subcutaneous formulation of RoActemra® (tocilizumab) gains CHMP positive opinion in Europe for moderate to severe rheumatoid arthritis

Roche and Chugai (SIX: RO, ROG; OTCQX: RHHBY) announced today that the subcutaneous formulation of RoActemra (tocilizumab) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of moderate to severe active rheumatoid arthritis (RA) in 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.

As with the intravenous (IV) formulation indication, the CHMP has recommended approval of the subcutaneous formulation for use both as monotherapy and in combination with methotrexate (MTX).¹

“This positive opinion from the CHMP is a step toward providing physicians and patients the flexibility to choose whether intravenous or subcutaneous RoActemra treatment is most appropriate for them,” said Hal Barron, M.D, Head of Global Product Development and Chief Medical Officer at Roche. “With the new RoActemra subcutaneous formulation adult patients or their caregiver will be able to administer the medicine at home after appropriate training.

The CHMP’s positive opinion is based on data from the phase III SUMMACTA and BREVACTA studies. SUMMACTA showed that the efficacy and tolerability of subcutaneous RoActemra was comparable with IV RoActemra.^2,3 The European Commission will now consider the positive opinion for its decision on the marketing authorisation for the subcutaneous formulation in the European Union. Upon approval, RoActemra would be the first humanized interleukin-6 (IL-6) receptor-antagonist biologic in subcutaneous and intravenous formulation for both monotherapy and combination therapy.

The subcutaneous formulation is administered under the skin and will be available via a prefilled syringe and a prefilled pen, a medical device designed for self-administration of a single dose of drug. The subcutaneous formulation was authorised in Japan and the United States earlier this year, where it is known as Actemra. The most common adverse reactions reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, elevated blood pressure, and increased liver enzymes. The serious adverse reactions reported in clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis.¹

A copy of the Summary of Product Characteristics is available at http://emc.medicines.org.uk/emc

References

1. RoActemra Summary of Product Characteristics. Available at http://www.ema.europa.eu/…www.medicines.org.uk/emc (Last accessed December, 2013).
2. Burmester G et al. A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study). Ann Rheum Dis 2013; 0:1–6. doi:10.1136/annrheumdis-2013-203523.
3. Kivitz A et al. A Randomized, Double-Blind, Parallel-Group Study of the Safety and Efficacy of Tocilizumab Subcutaneous Versus Placebo in Combination With Traditional DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis (BREVACTA). ACR, November 2012.