By Kanoko Matsuyama
Nov. 25 (Bloomberg) -- Chugai Pharmaceutical Co., the Japanese unit of Switzerland's Roche Holding AG, said a European advisory panel backed its experimental rheumatoid-arthritis treatment, bringing the product closer to approval for sale.
The European Committee for Medicinal Products for Human Use recommended the intravenous drip, known as RoActemra, on Nov. 20, Tokyo-based Chugai Pharma said in a statement today. The European Union's drug regulators usually follow the panel's advice.
Chugai Pharma is counting on RoActemra, known as Actemra outside Europe, to boost profit as rising competition erodes sales in Japan. The backing follows support in July from an advisory panel in the U.S., while regulators there requested more information in September.
``We expect a decision to be made by the EU regulators within three months,'' Hiroshi Araki, a spokesman for Chugai, said by telephone today.
Chugai Pharma, which is developing RoActemra with Roche, rose 3.4 percent to 1,572 yen at the close of trading in Tokyo, the biggest gain since Nov. 14. The stock has fallen 1.8 percent this year, compared with a 30 percent slump for the MSCI World Health-Care Index of 112 companies.
Rheumatoid arthritis occurs when the immune system attacks the joints, causing swelling, pain and damage that can lead to deformity and disability. The disease afflicts about 1.3 million Americans, according to the National Institutes of Health.
Factor Alpha
Actemra is aimed at patients who aren't helped by older treatments, known as TNF inhibitors, which block an immune-system protein called tumor necrosis factor-alpha. Amgen Inc.'s Enbrel, Johnson & Johnson's Remicade and Abbott Laboratories's Humira are in that class.
Chugai Pharma has sold Actemra in Japan since 2005 for Castlemans disease, a disorder of the immune system, and won approval from Japanese regulators to sell it for arthritis in April. The company submitted the medicine with Roche in November 2007 for European Union approval as a treatment against severe to moderate rheumatoid arthritis.
Actemra has been linked to increased cholesterol levels, changes in liver function and tears in the digestive tract. Some members of the U.S. Food and Drug Administration advisory panel said in July that the dose should be cut in half or limited to patients who don't respond to TNF-inhibitors, until Roche finishes a planned longer-term safety review of the drug.
Actemra, also known by its chemical name tocilizumab, works by blocking the activity of interleukin-6, a protein that initially stimulates and later hinders the body's healing process.
To contact the reporter on this story: Kanoko Matsuyama in Tokyo at kmatsuyama2@bloomberg.net.
Last Updated: November 25, 2008 01:40 EST
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