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Which regulatory bodies will approve BRIUMVI by end of 2024?
2
Resolution / Starting Odds
Only FDA • 25%
FDA and EMA • 25%
FDA, EMA, and MHRA • 25%
None • 25%
Official announcements from regulatory bodies like EMA, FDA, MHRA
Story
TG Therapeutics' BRIUMVI Shows Promising 5-Year Data with 30-Minute Infusions and 0.020 Relapse Rate
Sep 18, 2024, 11:21 AM
TG Therapeutics Inc. has released new data from the ENHANCE Phase 3b study on BRIUMVI® (ublituximab-xiiy), showing that rapid 30-minute infusions are well-tolerated in patients with relapsing forms of multiple sclerosis. The study also demonstrates that 92% of patients treated with BRIUMVI were free from disability progression after five years. Additionally, the annualized relapse rate during the fifth year of treatment was 0.020, equivalent to one relapse occurring every 50 years of patient treatment. The overall safety profile of BRIUMVI remained consistent over five years. Furthermore, data indicate that patients switching from prior anti-CD20 treatments can successfully eliminate the initial BRIUMVI infusion. These rapid infusions are being accomplished with non-drowsy pre-medications and no required post-infusion. Over 100k patients are already on CD20 treatments. These findings suggest that BRIUMVI could significantly enhance patient outcomes and market share for TG Therapeutics.
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European Medicines Agency (EMA) • 25%
Health Canada • 25%
Japan's PMDA • 25%
Other • 25%
European Medicines Agency (EMA) • 25%
Medicines and Healthcare products Regulatory Agency (MHRA) • 25%
Therapeutic Goods Administration (TGA) • 25%
Other • 25%
European Central Bank • 25%
BaFin (Germany) • 25%
US SEC • 25%
Other • 25%
FDA only • 25%
EMA only • 25%
Both FDA and EMA • 25%
Neither • 25%
FDA (USA) • 25%
EMA (EU) • 25%
MHRA (UK) • 25%
Other • 25%
FDA (US) • 25%
EMA (European Union) • 25%
MHRA (UK) • 25%
Other • 25%
FDA • 33%
EMA • 33%
Both • 34%
FDA (USA) • 25%
EMA (Europe) • 25%
MHRA (UK) • 25%
Other • 25%
Only in the US • 25%
Only in the EU • 25%
In both US and EU • 25%
In US, EU, and Japan • 25%
FDA • 25%
EMA • 25%
MHRA • 25%
Other • 25%