FDA: Roche's Actemra Appears
Effective in Rheumatoid Arthritis
By JARED A. FAVOLE and ANITA GREIL
July 25, 2008 12:46 p.m.
Roche Holding AG's Actemra appears effective at treating rheumatoid arthritis, a disease that can destroy joints and causes chronic pain for patients, the U.S. Food and Drug Administration said Friday.
The drug appears effective for treating patients with moderate to severely active rheumatoid arthritis, but has been linked to serious infections, malignancies and other problems, according to documents posted on the FDA's Web site Friday.
A panel of outside medical experts will meet Tuesday to discuss whether the benefits of Actemra outweigh the risks, and whether the drug should be approved. The FDA doesn't have to follow its panels' advice, but generally does.
Actemra is one of the Roche's most promising new products.
Deutsche Bank analysts said in a recent note that they are expecting a positive recommendation by the panel.
"This should add to Roche's premium growth potential, and add another asset to the immunology franchise," Deutsche Bank said. The bank expects the drug to generate sales of just 809 million Swiss francs ($778 million) in 2012 due to potential regulatory concerns and because many alternative treatments are available for rheumatoid arthritis and it will take some time until the drug has established itself.
Other estimates run much higher. JP Morgan analysts, for example, forecasts sales of CHF4.6 billion in 2012, equivalent to around 8% of Roche's prescription drug revenue.
Actemra, also known as tocilizumab, was developed by Japan's Chugai, which is controlled by Roche. Roche owns the rights to sell Actemra outside Japan. In Japan, the drug won approval in April.
Rheumatoid arthritis affects more than 2 million Americans. Sufferers of rheumatoid arthritis, or RA, begin to experience progressive joint damage early in the disease. The disease differs from what is popularly known as arthritis, typically associated with age-related joint pain, as RA is a far more serious inflammatory disease that leads to destruction of cartilage and bone, and can lead to disability.
There is already a large number of treatments available for rheumatoid arthritis, but many merely relieve pain, in some cases at the cost of severe long-term side effects, including osteoporosis and high blood pressure.
Actemra works by a different mechanism. It is a humanized monoclonal antibody -- an antibody produced by a single cell -- and the first to inhibit the interleukin-6, or IL-6, receptor.
IL-6 is considered an important mediator of the acute inflammatory response that underpins the rheumatoid arthritis disease process. Thus, Actemra targets a new mechanism of action compared to existing biologic agents, which are dominated by a type of drug known as anti-TNFs. TNF is a protein made by the body's immune system, which plays a key role in the development of inflammation.
Such therapies include Johnson & Johnson's blockbuster drug Remicade, Abbott Laboratories' Humira, and Enbrel, which is marketed by Wyeth Pharmaceuticals outside North America. In the U.S., Wyeth sells the drug jointly with Amgen.
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