US FDA approves phase 3 clinical trial plan for ‘Zimfentra’
Research to add RA indication to existing IBD
Jim Pentra US Market Expected to Expand 3-fold from ’13 Trillion Won to 39 Trillion Won’
22% share in Europe (EU5) where RA prescriptions are made
Ramsima (IV·SC) market share in EU5 Europe 75%
Celltrion announced on the 19th that the U.S. Food and Drug Administration (FDA) approved the Phase 3 clinical trial plan (IND) for adding the indication for rheumatoid arthritis (RA) of its autoimmune disease treatment drug ‘Zimfentra (Remsima SC)’.
Zimfentra is a tumor necrosis factor (TNF-α) inhibitor widely used in intravenous (IV) form treatment, and is a product that Celltrion first developed in a subcutaneous injection (SC) form. It was recognized as a new drug in the United States and was launched in the local market for the treatment of inflammatory bowel disease (IBD) through procedures similar to new drugs. This clinical trial is a study to expand the indication of Zimfentra, which was previously prescribed only for the treatment of IBD, to the treatment of RA.
RA is one of the representative autoimmune diseases in which the body’s immune system attacks healthy joint tissues, causing joint pain, swelling, stiffness, and loss of function. The phase 3 clinical trial is being conducted with a total of 189 RA patients to prove the efficacy and safety of Zimfentra by comparing it with a placebo control group. Celltrion expects that if it succeeds in securing RA indications, Zimfentra’s influence in the US market will be further strengthened.
Zimfentra is actually prescribed in Europe for the treatment of RA, including IBD. It is sold as Remsima SC in the European market. Its growth rate is also noteworthy. As of the first quarter of this year, it recorded a market share of 22% in the five major European countries (EU5) with just one product. Including Remsima, which is supplied in an intravenous (IV) formulation, Remsima’s market share in the EU5 is estimated to reach 75%. Since it is supplied in two formulations, medical staff can prescribe customized prescriptions according to the patient’s condition, and patients can receive treatment more efficiently. The high market share can be seen as proof of Remsima’s excellent efficacy in the medical field.
Celltrion plans to continue this European market performance in the US. According to IQVIA, a pharmaceutical market research firm, the global RA treatment market size was approximately KRW 55.1655 trillion as of last year. Of this, the US market size was KRW 39.7618 trillion, accounting for approximately 72% of the total. It was calculated to be approximately three times larger than the US IBD treatment market (KRW 13.4745 trillion). If the IBD and RA treatment market sizes are combined, Zimpentra’s target market in the US is expected to expand to approximately KRW 53.2363 trillion.
Zimfentra, which is prescribed in the US for IBD indications, is evaluated to have successfully established itself in the market. It is listed in the formularies of all three major US PBMs (Pharmacy Benefit Managers), including Express Scripts (ESI), and product supply is also being carried out smoothly based on Celltrion’s direct sales system.
A Celltrion official said, “Zimfentra, which is being prescribed smoothly as an RA treatment in Europe, has entered full-scale clinical procedures to secure additional indications in the U.S. We will do our best to ensure that the clinical trials proceed without a hitch so that Zimfentra can leap forward as a global blockbuster.”
Kim Min-beom, Donga.com reporter [email protected]
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2024-08-19 07:24:34