Amgen’s Amjevita receives FDA approval For Multiple Inflammatory Diseases

Amgen’s Amjevita receives FDA approval For Multiple Inflammatory Diseases

Amjevita has received approval from the US Food and Drug Administration (FDA) to treat adult patients with multiple inflammatory diseases. It has also been approved as a biosimilar for active polyarticular juvenile idiopathic arthritis.

However, health experts have been asked to review the approved use of Amjevita.

It could be prescribed to adults with moderately to severely active rheumatoid arthritis, Crohn’s disease, plaque psoriasis or active psoriatic arthritis.

According to the FDA, Amjevita has received the green signal after considering structural and functional characterization, data from animal research and human pharmacokinetic and pharmacodynamics, and after showing that Amgen- manufactured Amjevita is biosimilar to Humira, a drug approved in December 2002 and developed by AbbVie Inc.

“This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions”, said Janet Woodcock of the Center for Drug Evaluation and Research of the FDA.

It has also mentioned side-effects that Amjevita can cause, and most serious could be malignancies and infections. About the possible reactions, the FDA said that the common could be injection site reactions.

It has also been announced that as Amjevita has been approved as biosimilar to Humira, its labeling will also contain a Boxed Warning where health experts and patients will be warned about the risk associated with the treatment which may lead to hospitalization, or even death.

FDA, a federal agency within the US Department of Health and Human Services, also disclosed that the newly approved treatment must be dispensed with a patient Medication Guide which tells about the drugs’ uses and risks.



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