The drug is more effective at reducing symptoms of rheumatoid arthritis than existing biologic agents, which are dominated by a type of drug known as anti-TNFs. The new drug will target the drug for patients who failed anti-TNFs, such as Johnson & Johnson's drug Remicade and Abbott Laboratories' Humira, DowJones reported.
TNF is a protein made by the body's immune system, which plays a key role in the development of inflammation.
Rheumatoid arthritis is an immune system disorder which affects about 2.5 million Americans and usually strikes in early adulthood or middle age. Sufferers begin to experience progressive joint damage early in the disease, which can lead to disability. It is more serious than the disease arthritis, which is associated with age and is characterized by joint pain. Women are much more likely to suffer from the condition, which can lead to disability and an early death if untreated.
The drug is already being used in Japan since April this year and is developed by Japan's Chugai, which is controlled by Roche. Roche owns the rights to sell Actemra outside Japan.
Reacting to the news, shares of Chugai Pharmaceutical Co. rose to their highest point in a month in Tokyo trading. Chugai Pharma gained as much as 41 yen, or 2.5 percent, to 1,696 yen on the Tokyo Stock Exchange, the highest since June 30. The shares traded at 1,694 yen ($15.73) as of 9:17 a.m. local time.
The drug has some serious side effects including severe infections, liver abnormalities and damage to digestive organs.
If approved by the FDA, market analysts believe Actemra will bring in about $788 million to $4 billion in revenue beginning in 2012. The agency generally follows the recommendations of its advisors.
