FDA Approves Biosimilar Drug Erelzi for Rheumatoid Arthritis

Share this content:
FDA Approves Biosimilar Drug Erelzi for Rheumatoid Arthritis
FDA Approves Biosimilar Drug Erelzi for Rheumatoid Arthritis

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

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »

Drug Lookup

Browse drugs by: BrandGenericDisease

Trending Activities

All Professions



Sign up for myCME e-newsletters


More in Home

FDA Approves First Drug for Rare Form of Rickets

FDA Approves First Drug for Rare Form of ...

Crysvita approved for adults and children ages 1 year and older with x-linked hypophosphatemia

High FGF-23 Linked to Recurrent Cardiac Events After ACS

High FGF-23 Linked to Recurrent Cardiac Events After ...

FGF-23 in top quartile independently linked to greater risk of CV death, heart failure hospitalization

Medical Cannabis Not Recommended for Sleep Apnea

Medical Cannabis Not Recommended for Sleep Apnea

American Academy of Sleep Medicine says evidence insufficient to recommend cannabis for apnea

is free, fast, and customized just for you!

Already a member?

Sign In Now »