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AstraZeneca’ Ultomiris (ravulizumab-cwvz) Receives the US FDA’s Approval for the Treatment of Generalized Myasthenia Gravis

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AstraZeneca’ Ultomiris (ravulizumab-cwvz) Receives the US FDA’s Approval for the Treatment of Generalized Myasthenia Gravis

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  • The approval was based on the P-III (CHAMPION-MG) trial evaluating Ultomiris vs PBO in a ratio (1:1) in 175 patients with gMG across North America, EU, Asia-Pacific & Japan. Patients were continued into an OLE period, following completion of the randomized control period
  • The results showed that Ultomiris was found to be superior in the 1EPs of change from baseline in MG-ADL total score @26wks. & showed early effect & lasting improvement in daily living activities & reduce treatment burden with dosing q8w. The safety profile was consistent with P-III trials of Ultomiris in PNH & aHUS
  • Ultomiris’ regulatory submissions are currently under review with multiple authorities including in the EU & Japan

Ref: Businesswire | Image: AstraZeneca

Click here to­ read the full press release 

Senior Editor

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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