Sandoz, a Novartis (VTX: NOVN) division, has received approval from the European Commission (EC) for the use of Zessly (infliximab) in Europe, the company disclosed on Thursday.
Zessly blocks the action of tumour necrosis factor (TNF)-alpha in patients with certain autoimmune diseases where excess TNF-alpha activity can be harmful or cause the onset of disease. The drug inhibits an underlying cause of inflammation by blocking the action of TNF-alpha.
The EC has approved Zessly for use in all indications of the reference medicine, Remicade, which is marketed in Europe by MSD (NYSE: MRK) -- known as Merck in the US and Canada -- and is a registered trademark of Janssen Biotech Inc.
This means that Zessly has been approved as a treatment for diseases including rheumatoid arthritis, adult Crohn's disease, paediatric Crohn's disease, adult ulcerative colitis, paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
The EC's approval was based on a review of a comprehensive development programme which including analytics, preclinical and clinical data. This confirmed that Zessly matched the reference medicine in terms of safety, efficacy and quality.
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