Shots:

• CHMP has recommended expanding the existing marketing authorization for Remsima SC for five indications that include AS- CD- UC- PsA and psoriasis. The CHMP’s positive opinion follows EC’s MAA for the therapy granted in Nov’2019
• The CHMP’s opinion is based on data evaluating the PK- efficacy and safety between CT-P13 SC to CT-P13 IV in people with active CD and UC. Part 1 of the study showed overall clinical response as assessed by CDAI-70 with similar scores- clinical remission was high in the SC cohorts with comparable safety profile @54wks.
• The CHMP has recommended the 120 mg fixed dose of Remsima SC in adults regardless of the body weight- in both existing and newly added indications

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