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
Delta Airlines becomes the latest airline to experience pet transport disaster. An 8-week-old puppy was flown across the country to the wrong airports by Delta Airlines landing in Detroit, Las Vegas and Salt Lake City before finally making to Idaho. On Saturday, a breeder put Josh Schlaich's new,... Facebook stock is plunging due to self-inflicted wounds. What was once America's favorite social media site is being a accused of turning into a cesspool of misinformation and narcissism. Facebook Inc.'s security chief, Alex Stamos, plans to step down from the company amid questions over Russia's... Media company Tronc, Inc. said Monday that Michael Ferro has stepped down as chairman of its board of directors. The company named Chief Executive Justin Dearborn as chairman of the board. Tronc noted that Ferro, its largest shareholder, is retiring from the board as the company prepares to close on the $500 million sale of its flagship newspaper, the Los Angeles Times, to local ownership.
comments powered by Disqus
Follow RTT