See What HealthDay Can Do For You
Contact Us

FDA Approves Biosimilar Drug Erelzi for Rheumatoid Arthritis

Erelzi is a biosimilar for Enbrel; treats RA and other inflammatory diseases

fda logo

THURSDAY, Sept. 1, 2016 (HealthDay News) -- A new biological drug to treat rheumatoid arthritis and other inflammatory diseases has been approved by the U.S. Food and Drug Administration.

The drug Erelzi (etanercept-szzs) is biosimilar to Enbrel (etanercept), which was approved by the FDA in 1998.

According to the FDA, Erelzi is given by injection to treat moderate to severe rheumatoid arthritis, either as a stand-alone therapy or in combination with methotrexate; moderate to severe polyarticular juvenile idiopathic arthritis in patients aged 2 and older; active psoriatic arthritis, including use in combination with methotrexate in psoriatic arthritis patients who do not respond adequately to methotrexate alone; active ankylosing spondylitis; and chronic moderate to severe plaque psoriasis in patients aged 18 and older who are candidates for systemic therapy or phototherapy.

The most common side effects of Erelzi are infection and injection site reactions. The most serious known side effects are infections, neurological events, congestive heart failure, and hematologic events. The drug should not be given to patients with sepsis, the FDA said. Erelzi carries a boxed warning about an increased risk of serious infections leading to hospitalization or death. The boxed warning also notes that lymphoma and other cancers, some fatal, have been reported in children and teens treated with tumor necrosis factor blockers, including etanercept products.

More Information

Physician's Briefing

HealthDay

HealthDay is the world’s largest syndicator of health news and content, and providers of custom health/medical content.

Consumer Health News

A health news feed, reviewing the latest and most topical health stories.

Professional News

A news feed for Health Care Professionals (HCPs), reviewing latest medical research and approvals.