Health Canada Approves Roche’s ACTEMRA® (tocilizumab) to Treat GCA
Hoffmann-La Roche Limited (Roche Canada) has now received a go-ahead from Health Canada for its ACTEMRA® (tocilizumab) to treat adult patients with giant cell arteritis (GCA).
ACTEMRA is designed to directly target the interleukin-6 (IL-6) receptor, a protein that is made by the immune system, which the body uses to manage infections and plays a major role in the signs and symptoms of GCA. There have been no new treatments in more than 50 years.
It is a recombinant humanized anti-human IL-6 receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H2L2 polypeptide structure. ACTEMRA is composed of two heterodimers, and each of the heterodimers is composed of a heavy (H) and a light (L) polypeptide chain. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. ACTEMRA has a molecular weight of approximately 148 kDa.
ACTEMRA is administered through subcutaneous (SC) injection and is supplied as a sterile yellowish, preservative-free liquid at a concentration of 162 mg/0.9 mL. Ready-to-use, single-use pre-filled syringes with the needle safety device are available.
The approval
was based on the outcome of the phase III GiACTA study, which showed that ACTEMRA, initially combined with a six-month steroid taper, sustained remission at one year in 56 percent and 53 percent of patients (with the weekly and bi-weekly doses respectively), compared to 14 percent of patients in the placebo arm with a six-month steroid taper given alone.“When GCA is diagnosed too late or left untreated, it can cause serious, even potentially life-threatening, complications,” says Dr. Christian Pagnoux, Internal Medicine Specialist and Rheumatologist at Mount Sinai Hospital in Toronto. “Treatment of GCA patients was limited to high-dose, long-duration steroids, and relapses were almost constant. The approval of Actemra provides physicians in Canada with a new treatment option.“