Health Canada approves ACTEMRA® (tocilizumab) for use in patients with early rheumatoid arthritis (RA)

MISSISSAUGA, ON, Jan. 8, 2015 /CNW/ - Roche Canada announced that it has received Health Canada approval for ACTEMRA^® (tocilizumab) intravenous and subcutaneous formulations for use to reduce signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). ACTEMRA^® is the first and only interleukin-6 (IL-6) receptor antagonist to be approved for use in Canada in patients with RA who have not been previously treated with methotrexate (MTX) for their disease (early RA).¹

"As one of the clinicians in this multi-national trial, I observed that patients with active early rheumatoid arthritis who had a high chance of developing damage and disability benefitted from treatment with ACTEMRA, and as a rheumatologist, my goal is to prevent irreversible long term effects in patients with RA.  The study results support previous data showing ACTEMRA to be beneficial in other scenarios in RA, and it is now the first IL-6 receptor antagonist approved for early RA, addressing the need for alternative treatment options to anti-tumor-necrosis-factor (anti- TNF) therapies in this debilitating condition," says Dr. Janet Pope, rheumatologist at St. Joseph's Health Care in London, ON. "The approval of ACTEMRA for the treatment of early RA is significant news for patients as it presents another treatment option."

The approval was based on data from the phase III FUNCTION study, which assessed the efficacy, safety and prevention of structural joint damage in patients with early moderate-to-severe  RA 3(defined as ≤2 years since diagnosis) not previously treated with MTX.² The study met its primary endpoint, demonstrating that patients who received ACTEMRA^® in combination with MTX or as a single agent therapy (monotherapy) experienced a significantly greater improvement in disease activity (DAS28 remission) after 24 weeks compared to patients who received MTX alone.²

The data also demonstrated that treatment with ACTEMRA^® with and without MTX achieved greater inhibition of structural joint damage compared with MTX alone (i.e. less joint damage).²  At 24 weeks, the overall safety of ACTEMRA^® in this early RA population was consistent with its known safety profile seen previously in other ACTEMRA^® studies in RA.²

The early RA approval is the fifth update to the Canadian indication in four years that covers adult and pediatric patient populations.

About Rheumatoid Arthritis (RA)
RA is thought to affect about one per cent of the population worldwide³, and has both an emotional and physical impact on a person's quality of life. Physically, RA causes individuals to experience morning stiffness, lack of flexibility, tiredness, pain, and joint swelling, while emotionally, it leaves a large number of patients feeling isolated and alone. In Canada, RA affects about 300,000 individuals, or one in every 100.⁴

RA is a progressive autoimmune disease characterized by inflammation of the membrane lining in the joints throughout the body. This inflammation causes distortion of the joint and impaired function accompanied by pain, stiffness and swelling, ultimately leading to irreversible joint destruction and disability. In addition, the systemic symptoms of RA include fatigue, anemia, and osteoporosis, and may contribute to shortening life expectancy by affecting major organ systems. Furthermore, musculoskeletal conditions, including arthritis, are the second most costly category of diseases in Canada at $16.4 billion.⁵

About ACTEMRA^® (tocilizumab)
ACTEMRA^®, is the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).¹  ACTEMRA^® is to be given in combination with methotrexate (MTX) or other DMARDs; however, in cases of intolerance to MTX or where treatment with MTX is not appropriate ACTEMRA^® may also be given as monotherapy.¹

The extensive ACTEMRA^® clinical development program included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including Canada.  ACTEMRA^® is also approved for the treatment of active systemic juvenile idiopathic arthritis (sJIA) and polyarticular-course juvenile idiopathic arthritis (pJIA) in patients two years of age and older.¹

ACTEMRA^® is part of a co-development agreement with Chugai Pharmaceutical Co. It has been approved in Japan since April 2005 for Castleman's disease, followed by approvals for RA, sJIA and pJIA in 2008. ACTEMRA^® is approved in Canada, and several other countries, including the United States, the European Union, China, India, Brazil, Switzerland and Australia.

About ACTEMRA^® Subcutaneous
ACTEMRA^® (tocilizumab) subcutaneous is a formulation of ACTEMRA^® designed to be administered via injection under the skin. It complements the intravenous (IV) formulation that is infused into a vein over a one-hour period in a hospital setting. The subcutaneous formulation of ACTEMRA^®, along with the IV formulation, allows physicians more flexibility to tailor the treatment to different RA patient's needs.

The ACTEMRA^® subcutaneous formulation comes in a pre-filled syringe and has comparable efficacy and safety to the established IV formulation.^7,8  Subcutaneous administration via the pre-filled syringe takes approximately 15 seconds. Under the guidance of a healthcare practitioner and after appropriate training, adult patients or the patient's caregiver will be able to administer ACTEMRA^® via pre-filled syringe at home.¹

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a front runner in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty- four medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013, the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References

1. ACTEMRA^® Product Monograph. Approved December 23, 2014. (Accessed December 2014).
2. Burmester G, et al. Tocilizumab (TCZ) in combination and monotherapy versus methotrexate (MTX) in MTX-naïve patients (pts) with early rheumatoid arthritis (RA): Clinical and radiographic outcomes from a randomized, placebo-controlled trial. Oral presentation at EULAR, 2013
3. Johns Hopkins Arthritis Center. Rheumatoid Arthritis Signs and Symptoms. Retrieved April 3 from http://www.hopkinsarthritis.org/arthritis-info/rheumatoid-arthritis/ra-symptoms/      
4. The Arthritis Society. Rheumatoid Arthritis. Retrieved April 3 from http://www.arthritis.ca/document.doc?id=336
5. Statistics Canada. Arthritis in Canada. Retrieved April 3 from http://www.acreu.ca/pdf/Arthritis_in_Canada.pdf
6. Smolen J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 0:1–18. doi:10.1136/annrheumdis-2013-20457.
7. Ogata A et al. A Phase 3 Study of the Efficacy and Safety of Subcutaneous Versus Intravenous Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis (MUSASHI). Pages 22,23. August 5, 2013.
8. Burmester GR et al. The Efficacy and Safety of Tocilizumab Subcutaneous Versus Tocilizumab Intravenous, in Combination With Traditional DMARDs in Patients With RA at 49 Weeks (SUMMACTA), ACR, October 2013

SOURCE Roche Canada

Morgan Cates, Environics Communications, 416-969-2789, [email protected], Ashley Iyer, Roche Canada, 905-542-5907, [email protected]