Argenx Receives CHMP Positive Opinion of Efgartigimod as an Add-on to Standard Therapy for Generalized Myasthenia Gravis
Shots:
- The EMA’s CHMP has recommended EC's approval of efgartigimod for gMG in adult patients who are AChR Ab+. The EC’s decision on MAA is expected within ~60 days, following CHMP recommendation & will be valid in all 27 EU Member States, Iceland, Norway & Liechtenstein
- The opinion was based on the P-III (ADAPT) trial evaluating efgartigimod vs PBO in a ratio (1:1) in 167 adult patients with gMG across North America, the EU & Japan. The trial met its 1EPs i.e., (68% vs 30%) AChR Ab+ gMG patients were responded on MG-ADL scale., 63% vs 14% on QMG scale
- Responders experienced a 3-point decline on the MG-ADL scale for ≥4 consecutive wks. during 1st treatment cycle. If efgartigimod is approved, it will be the 1st FcRn blocker for gMG in the EU
Ref: GlobalNewswire | Image: argenx
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