Baxalta Received CHMP Positive Opinion for Veyvondi for the treatment of Bleeding Episodes in patients with von Willebrand disease
Shots:
- The positive opinion was for the extension of indication to include "prophylactic treatment to prevent or reduce the frequency of bleeding episodes based on the results from study 071301 & study SHP677-304
- Study 071301 is a prospective, P-III, global, multicentre study on efficacy and safety of prophylaxis with rVWF in severe von Willebrand disease whereas study SHP677-304 is a P-IIIB, a prospective study to assess the long-term safety and efficacy of rVWF in pediatric and adult subjects with severe von Willebrand disease
- Veyvondi is an is a recombinant von Willebrand factor. It has been approved in EU since Sep 2018 in adult patients with von Willebrand Disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or not indicated for the treatment of hemorrhage and surgical bleeding & prevention of surgical bleeding
Ref: European Medicines Agency | Image: Baxalta
*Note: This is not an original PR, this reference is taken based on European Medicines Agency website
Related News:- Shire Receives EU's MAA for VEYVONDI for the Treatment of von Willebrand disease in adults
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
