Roche’s Arthritis Drug Actemra™ Got Japanese Approval

Roche Holding AG‘s arthritis drug Actemra™ just won Japanese approval, which will then be sold by Roche’s Chugai unit.

Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development program of five Phase III trials was designed to evaluate clinical findings of Actemra.

Four studies are completed and have reported meeting their primary endpoints. A fifth trial, a two-year study called LITHE (TociLIzumab safety and THE prevention of structural joint damage), is currently underway and is expected to report preliminary first-year data in 2008.

Actemra™ (tocilizumab) will be sold for rheumatoid arthritis and two types of the disease that affect children: namely juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis.

The therapy is aimed at patients who aren’t helped by older drugs marketed by Amgen Inc., Johnson & Johnson and Abbott Laboratories. Roche is seeking to expand its range of treatments with medicines for arthritis, diabetes and anemia.

Roche expects the market for rheumatoid arthritis to grow to 15.6 billion Swiss francs ($15.5 billion) by 2010 from 8.6 billion francs in 2005. The Swiss drugmaker has also asked U.S. and European regulators to approve the medicine.

While the Japanese approval is the first worldwide approval for Actemra™, the FDA in the United States has yet to approve this drug. The FDA’s decision is expected by September 21, 1008.

Actemra™ works by targeting a different protein — called interleukin-6 — which also causes inflammation and also other symptoms such as fever, pain and stiffness.

Actemra is the first of a new class of drug with a novel mechanism of action that brings new hope to RA patients. It is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, which works by suppressing the activity of IL-6, an important trigger of the inflammatory process. This novel mode of action reduces inflammation of the joints and relieves the systemic effects of RA.

Since 2005, Actemra has been marketed in Japan for the treatment of patients with a rare auto-immume condition known as Castleman’s disease. Actemra licence applications have also been filed for treatment of RA in the Unites States and the European Union in 2007, and are currently under review.

Rheumatoid arthritis (RA), as we all know is debilitating, it is an autoimmune disease. In fact (according to Roche), RA is a high unmet medical need!

Rheumatoid arthritis 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 and ultimately leading to irreversible joint destruction and disability.

In addition, the systemic symptoms of RA include fatigue, anaemia, osteoporosis and may contribute to shortening life expectancy by affecting major organ systems. Sadly after 10 years, less than 50% of patients can continue to work or function normally on a daily basis.

Read the full report at Bloomberg and Roche PR.