FDA OKs Genentech's new arthritis drug

Federal regulators have approved a new class of rheumatoid arthritis drug created by South San Francisco's Genentech.

The drug, called Actemra, is the first arthritis treatment to operate by blocking the activity of a protein called interleukin-6 that, when overly abundant in the body, causes inflammation in the joints associated with arthritis। The Food and Drug Administration approved the drug Friday।

"This is the ninth biologic to hit the market to treat rheumatoid arthritis, but the only one that targets IL-6," said Dr। Mark Genovese, co-chief of Stanford University's immunology and rheumatology division and the new drug's study investigator.

Genovese said the drug will provide an option for people who respond inadequately to existing therapies, such as Remicade, marketed by Johnson & Johnson, Abbott's Humira and Pfizer's Enbrel. Those treatments, which are among the top-selling drugs in the country, act on another inflammatory protein called tumor necrosis factor-alpha, or TNF.

About 30 to 50 percent of people do not respond well to TNF inhibitors, Genovese said. The reason is unknown.

Rheumatoid arthritis is an autoimmune disorder that causes pain, swelling and eventually damage to joints. About 1.3 million American adults are affected by the disease, according to the Arthritis Foundation.

Officials with the Roche Group, parent company of Genentech, estimated the cost of Actemra at $1,060 to $2,125 a month, depending on the dose. The prices of other biologics used for rheumatoid arthritis range from $194 to $2,768 per vial, the company said.

The drug will be available the week of Jan. 18, according to Roche.

read more» Read more...