Shots:
- FDA has approved a label extension for Vonvendi to incl. routine prophylaxis for reducing bleeding in adults with Type 1 & 2 von Willebrand disease (VWD), & for on-demand & perioperative bleeding management in pediatric pts
- Approval was backed by extensive data, incl. a P-III trial in adults, a P-III trial in children, a P-IIIb continuation study across both groups, & additional real-world data. Trials showed that most non-surgical bleeds were controlled with Vonvendi in both adults (157/192) & children (80/104)
- Also, Takeda has filed applications for Vonvendi in Japan for on-demand & perioperative bleeding management in pediatric VWD pts, & for Veyvondi (vonicog alfa) in the EU for on-demand use in pediatric VWD pts
Ref: Takeda | Image: Takeda| Press Release
Related News:- Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1)
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