Celltrion Remsima Approved by EU

| By | Celltrion, European Commission
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Celltrion has revealed data from its Remsima SC (infliximab) trials, evaluating a subcutaneous (SC) biosimilar version of the treatment in patients with Chron’s disease, ulcerative colitis and rheumatoid arthritis.

On top of the positive data, the drug has been granted European Commission approval for patients with rheumatoid arthritis, marking it as the world’s first approved subcutaneous formulation of infliximab.

“The approval gives patients the opportunity to administer the treatment themselves as an injection, giving them more control over their own treatment”,

said Professor Rene Westhovens, a rheumatologist at the University Hospitals KU Leuven, Belgium.

Westhovens continued to say that

“Remsima SC has been shown to have a stable potency, and patients with RA on Remsima SC develop fewer anti-drug antibodies – which can improve the effectiveness of a treatment – compared with those on CT-P13 IV”.

The successful data showed that the clinical response and remission rates in both indications of irritable bowel disease (IBD) patients combined were not statistically different between the SC and intravenous (IV) versions of the drug.

Further to the successful remission rates, the portion of patients with positive ADA throughout the trial was found to be slightly lower in the SC arm than the IV.

The company also revealed that in the rheumatoid arthritis study, the efficacy up to Week 54 showed a similar trend between both the SC and IV applications, even after switching from IV to SC treatment at Week 30.

Non-inferior efficacy was therefore demonstrated, and additionally comparable pharmacokinetics and safety profiles were also observed.

The anti-TNF drug works by targeting a protein in the body called TNF-alpha, which is naturally produced as part of an immune response to help fight infections by temporarily causing inflammation in affected areas.

On the 19th September this year the European Medicines Agency’s (EMA) human medicines committee (CHMP) issued a positive opinion for the subcutaneous version of the drug, also known as CT-P13, as a line extension, and the data from the trials was submitted to the EMA as part of the application.

Celltrion has also announced the submission of a further variation to the marketing authorisation of Remsima SC, in order to extend the indication to inflammatory bowel disease with the approval decision expected in mid-2020.

SOURCE: pharmatimes.com
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