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
Low-cost airline Allegiant Air announced its order for brand-new aircraft for the first time in its history. The carrier announced on Friday it had reached a deal to purchase 12 current-generation models of Airbus' A320 narrow-body jets. The company termed the deal as "another step towards Allegiant's... Los Angeles City officials have filed criminal charges against Soylent CEO Robert Rhinehart for placing a bright red shipping container on Montecito Heights hillside as part of his "experiment in sustainable living." City Attorney Mike Feuer Friday announced that his office has filed multiple criminal... A new study says that if Hillary Clinton is elected then her proposals will strengthen the U.S. economy and create millions of jobs. According to Moody's Analytics, Hillary Clinton's economic proposal would oversee a "somewhat stronger U.S. economy." The conclusion was reached after assessing her...
comments powered by Disqus
Follow RTT