Research & Development
Amgen receives FDA approval for AVSOLA (infliximab-axxq) across inflammation portfolio
9 December 2019 -

Human therapeutics company Amgen (NASDAQ:AMGN) disclosed on Friday the receipt of approval from the US Food and Drug Administration (FDA) for AVSOLA (infliximab-axxq) for all the same approved indications of the reference product Remicade (infliximab) across inflammation portfolios.

The US FDA has approved the company's AVSOLA (infliximab-axxq) for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn's Disease (CD) in the adult and paediatric population, moderate-to-severe ulcerative colitis (UC) in the adult and paediatric population, chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).

According to the company, AVSOLA is a biosimilar to Remicade, an anti-tumour necrosis factor alpha (anti-TNF) monoclonal antibody. The active ingredient of AVSOLA is an anti-TNF monoclonal antibody that has the same amino acid sequence as Remicade. AVSOLA also has the same pharmaceutical dosage form and strength as Remicade. AVSOLA is currently not available

In conjunction, the company's randomised, double-blind comparative clinical study evaluated the efficacy and safety of AVSOLA compared to Remicade in patients with moderate-to-severe RA. There were 558 patients enrolled and randomised (1:1) to receive either AVSOLA or Remicade at a dose of 3 mg/kg administered as an infusion on day one, at weeks two and six, and every eight weeks thereafter.

Under the company's the company's randomized, double-blind comparative clinical study, the primary endpoint was the response difference (RD) of 20% improvement in American College of Rheumatology core set measurements (ACR20) at week 22.

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