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UCB Reports the US FDA Acceptance of NDA and EMA’s Validation of MAA for Zilucoplan to Treat Generalized Myasthenia Gravis

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UCB Reports the US FDA Acceptance of NDA and EMA’s Validation of MAA for Zilucoplan to Treat Generalized Myasthenia Gravis

UCB Reports the US FDA Acceptance of NDA and EMA’s Validation of MAA for Zilucoplan to Treat Generalized Myasthenia Gravis

Shots:

  • The US FDA has accepted the NDA of zilucoplan for review in adult patients with AChR-Ab+ gMG along with EMA validation of MAA. All patients continued in (RAISE-XT) OLE study, upon completion of 12wk. treatment period
  • The NDA & MAA were based on the P-III (RAISE) study evaluating zilucoplan (0.3mg/kg, qd) vs PBO in 174 patients. The study met its 1EPs of mean improvement of 2.09 points in MG-ADL score @12wk., favorable safety & tolerability profile which showed a similar rate of TEAEs (76.7% vs 70.5%)
  • Low rates of treatment discontinuation due to a TEAE. The 2EPs incl. change in QMG score, MGC & the MG-QoL15r score from baseline to 12wk, time to rescue therapy, the proportion of patients with MS; ≥3-point reduction in MG-ADL; ≥5-point in QMG without rescue therapy @12wk.

Ref: PRNewswire  | Image: UCB

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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