Baxalta files for approval of hemophilia drug Adynovi with EMA

3 March 2016
2019_biotech_test_vial_discovery_big

US biotech firm Baxalta (NYSE: BXLT) has submitted a Marketing Authorization Applicationto the European Medicines Agency for approval of Adynovi, an extended circulating half-life recombinant Factor VIII (rFVIII) treatment,for pediatric, adolescent and adult patients with hemophilia A and for use during surgery.

Currently licensed in the USA as Adynovate [Antihemophilic Factor (Recombinant), PEGylated] (The Pharma Letter November 14, 2015) and under regulatory review in Japan, Canada and Switzerland, Adynovi is the only rFVIII treatment for hemophilia A developed based on the demonstrated efficacy of Advate [Antihemophilic Factor (recombinant)].

''We are dedicated to bringing Adynovi to hemophilia A patients all over the world,'' said Brian Goff, executive vice president and president, Hematology, Baxalta,'' adding: “As we build on our market-leading portfolio of direct factor replacement treatments, we continually bring new options to hemophilia patients, empowering them to manage their hemophilia, with their caregivers, in the way that works best for them.''

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Today's issue

Company Spotlight





More Features in Biotechnology