logo
Share SHARE
FONT-SIZE Plus   Neg

Genentech: FDA Approves Expanded Indication For Actemra In Rheumatoid Arthritis

Genentech Inc., a member of the Roche Group (RHHBY.PK), announced that the U.S. Food and Drug Administration or FDA has expanded the approved indication for Actemra or tocilizumab for the treatment of adults with moderately to severely active rheumatoid arthritis or RA who have had an inadequate response to one or more disease-modifying antirheumatic drugs or DMARDs.

The company noted that Actemra can be used both alone as a single-agent therapy and in combination with methotrexate or MTX or other Dmards. The expanded indication further supports the safety and efficacy profile of Actemra.

Rheumatoid arthritis (RA) is an autoimmune disease estimated to affect up to 70 million people worldwide, including children. Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged.

Actemra is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying antirheumatic drugs or DMARDs. In addition, Actemra is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older.

The company said that some people have serious infections while taking Actemra, including tuberculosis, and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Common side effects with Actemra in rheumatoid arthritis include upper respiratory tract infections (common cold, sinus infections), headache, and increased blood pressure (hypertension).

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
American Express did not violate antitrust laws and can prohibit merchants from steering customers to credit cards with lower transaction fees, a federal appeals court ruled Monday. This ruling reverses an earlier trial court's judgment against the company and directs that court to enter judgment in favor of American Express. General Motors (GM) luxury brand is offering 400 dealers as it reshapes the brand's image to better compete with rivals, according to media reports. The Detroit auto maker will provide as much as $180,000 in "transition assistance" to U.S. Cadillac dealers unwilling to invest in a set of new standards... Hotwire of Expedia Inc. cautioned customers about a fake fax memo. The memo, offering deep travel discounts, has an old corporate Hotwire logo in it to falsely imply a connection with Hotwire. It carries phone numbers which are not related to travel booking site.
comments powered by Disqus
Follow RTT