Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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).

Register
To receive FREE breaking news email alerts for Roche Holding AG and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Swiss drug maker Roche Holding said a late-stage trial of its breast cancer drug Kadcyla did not provide superior results compared with an existing therapy. FCA US, until recently known as Chrysler, said Friday it is recalling 257,000 Dodge Ram pickups. The auto maker says the rear axle pinion nut on certain model year 2005 Dodge Ram 1500 trucks may loosen due to an undersized spline on the pinion gear. If the pinion nut loosens, the rear axle may... This medical device company has a very impressive track record of growing business over the past decade. increasing sales from $490.2 million in 2004 to $1.72 billion this year. The Silicone Hydrogel daily disposable lens portfolio constitutes a major avenue for growth.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.