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TG Therapeutics Receives EMA’s CHMP Positive Opinion of Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis

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TG Therapeutics

TG Therapeutics Receives EMA’s CHMP Positive Opinion of Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis

Shots:

  • The EMA’s CHMP has issued a positive opinion recommending the approval of Briumvi for adult patients with RMS with active disease defined by clinical or imaging features. The EC’s decision is expected in ~2mos.
  • The opinion was based on the P-III trials (ULTIMATE I & II) evaluating Briumvi vs teriflunomide in 1094 patients across 10 countries. The trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University
  • The results showed superiority over teriflunomide in reducing the ARR, the no. of T1 Gd-enhancing lesions & new or enlarging T2 lesions. The results were published in the NEJM. The centralized marketing authorization was valid in all EU MEMBER States, Iceland, Norway & Liechtenstein

Ref: TG Therapeutics | Image: TG Therapeutics

Related News:- TG Therapeutics’ Briumvi (ublituximab-xiiy) Receives the US FDA’s Approval for Relapsing Multiple Sclerosis

Click here to­ read the full press release 

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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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