New biologic drug for rheumatoid arthritis approved by the FDA

By: Mohan Garikiparithi | Health News | Thursday, September 01, 2016 - 10:30 AM

New biologic drug for rheumatoid arthritis approved by the FDAThe FDA has recently approved a new biologic drug to treat rheumatoid arthritis and other inflammatory diseases. Known as Erelzi, the drug is a biosimilar for Enbrel, which was previously approved by the FDA.

A biosimilar is a biological drug approved based on findings that it is highly similar to an already-approved treatment, with no clinically significant differences in effectiveness or side effects. The drug is similar to generic drugs as it typically costs less than the original product.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a news release, “The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases. We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product [Enbrel].”

Erelzi is administered through injection to treat moderate to severe rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spondylitis, and chronic moderate to severe plaque psoriasis.

The most common side effects of Erelzi are infection and injection site reactions. More serious side effects include neurological problems, congestive heart failure, and blood problems. The drug should not be given to patients with sepsis. The box label does outline detailed warnings with regards to other possible side effects and adverse reactions associated with Erelzi.

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