U.S. FDA approves ACTEMRA

ROCHE (SIX: RO, ROG; OTCQX: RHHBY) has announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous formulation of ACTEMRA (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate, that did not provide enough relief.

ACTEMRA is the first and only humanised interleukin-6 receptor-antagonist monoclonal antibody approved by the FDA for both subcutaneous and intravenous administration in rheumatoid arthritis. Like the intravenous (IV) formulation, the subcutaneous (SC) formulation can be used both as a single-agent therapy and in combination with methotrexate or other non-biologic DMARDs. The ACTEMRA pre-filled syringe injection formulation will be available in early November.

"People with moderately to severely active rheumatoid arthritis can suffer irreversible joint damage that may be prevented by earlier treatment with a medicine such as Actemra," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We're pleased that these patients will now have the option of Actemra as a subcutaneous injection or an IV infusion."

RA is an autoimmune disease estimated to affect up to 70 million people worldwide [1]. Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged. [2]

ACTEMRA, originally approved by the FDA as an IV medicine in 2010, is the first and only humanised interleukin-6 (IL-6) receptor-antagonist monoclonal antibody approved by the FDA for both SC and IV administration.

The approval is based on data from the phase III clinical trials SUMMACTA [3] and BREVACTA [4]. For ACTEMRA SC, the FDA recommended dosage is 162 mg administered subcutaneously every other week, followed by an increase to 162 mg every week based on clinical response for patients less than 100 kg (220 lbs) in weight. For patients at or above 100 kg (220 lbs), the dosing is 162 mg administered subcutaneously every week.

This is the sixth FDA approval for ACTEMRA in four years, following previous approvals for the treatment of adults with moderately to severely active rheumatoid arthritis and children two years of age and older with active polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

1 World Health Organisation. Chronic rheumatic conditions. http://www.who.int/chp/topics/rheumatic/en/ (Last accessed Oct 2013).
2 Patient UK. Rheumatoid arthritis. http://www.patient.co.uk/health/rheumatoid-arthritis (Last accessed Oct 2013).

3 SUMMACTA is a randomised, double-blind, active controlled, parallel group, multicentre study with a double-blind period of 24 weeks in 1,262 patients with moderately to severely active RA. SUMMACTA demonstrated comparable efficacy (non-inferiority) of the SCGirls Air Jordan 1