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
Just over a year in market and it is getting out from the stores - That's going to be the fate for Microsoft's affordable Windows tablet, the Surface 3. The firm reportedly has confirmed its plans to end the production of the Surface 3 by the end of December 2016, citing the limited inventory for the device. Delta Air Lines Inc. (DAL) pilots, represented by the Air Line Pilots Association International, are picketing on Friday at several airports across the country. The pilots said the picketing was to raise the sense of urgency in ongoing contract negotiations. The negotiations between the pilots... Charter Communications, and its recently acquired subsidiary Time Warner Cable, have been regularly overcharging its consumers to a tune of $7.2 million per year, according to a report from the U.S. Senate's Permanent Subcommittee on Investigations. According to the report, Time Warner Cable over-billed...
comments powered by Disqus
Follow RTT