Actemra close to US approval
pharmafile | August 8, 2008 | News story | Sales and Marketing |
US regulars have recommended Roche's Actemra (tocilizumab) be approved to treat adults with moderate to severe rheumatoid arthritis (RA).
The FDA's arthritis advisory committee voted overwhelmingly to recommend the brand, which received its first green light in Japan earlier this year.
Roche already has some experience of the RA market. Its cancer drug MabThera was approved in Europe two years ago to treat severe stages of the autoimmune disease.
Actemra was developed with Roche's Japanese offshoot Chugai and is the first interleukin-6 inhibitor (IL-6) to offer a new therapeutic option for RA. The debilitating disease causes inflammation of the membrane lining in the joints throughout the body, causing pain, stiffness and swelling, and leading to disability.
Actemra works by suppressing the activity of IL-6, an important trigger of the inflammatory process, and analysts have forecast annual sales of more than $1 billion.
"We are pleased with the FDA advisory committee's very positive recommendation for Actemra, which helps move this promising new therapy closer to becoming available for patients who suffer from the debilitating symptoms of RA," said William Burns, chief executive of Roche's Pharmaceuticals Division.
"We remain hopeful that the FDA will approve Actemra for the treatment of RA and provide a new option to patients who are not achieving adequate symptom relief with current therapies."
Its main competitors will be Abbott's Humira, Wyeth's Enbrel and Schering-Plough's Remicade, the three TNF (tumour necrosis factor)-blockers that currently dominate the market.
Humira, Enbrel and Remicade have all successfully expanded their indications from RA to other autoimmune diseases.
Successful clinical trials in Japan showed Actemra reduces inflammation of the joints and controls the symptoms and progression of the disease. The drug was approved there for auto-immune condition Castleman's disease three years ago and had additional indications for RA, polyarticular-course juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis approved in April.
Roche presented results to the FDA from five phase III clinical trials, three of which were conducted in patients with inadequate response to disease modifying anti-rheumatic drugs. Another was with patients who failed anti-TNF therapy while the fifth compared Actemra to standard treatment methotrexate. Results showed that Actemra, alone or combined, reduced RA symptoms regardless of previous therapy or disease severity. The most common adverse events reported in clinical trials were upper respiratory tract infection, nasopharyngitis, headache and hypertension.
