- 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
Click here to read full press release/ article | Ref: Celltrion | Image: Fortune