The FDA approved Irish biopharma Shire’s ($SHPG) Baxject III reconstitution system for Adynovate, which reduces the number of steps in the reconstitution process for hemophilia A patients and caregivers.
The system was designed to eliminate two steps in the treatment process versus the previous process with the Baxject II Hi Flow Needleless transfer device, the company said. It’s expected the new system will be available in the U.S. market by the end of the year.
“We're pleased to provide our hemophilia A patients with a new option that will enable them to prepare their treatment with fewer steps," Perry Sternberg, head of Shire’s U.S. Commercial Organization, said in a statement. "Streamlining the process may minimize opportunities for reconstitution errors, helping to ensure patients can get the full benefit of their treatment."
Adynovate, which was approved by the regulatory agency in 2015 for use in hemophilia A patients 12 and older, is an extended circulating half-life recombinant Factor VIII treatment built on the protein of Advate and is used for the treatment and control of bleeding, and to reduce the number of bleeding episodes. Earlier this year, Baxalta, which is now part of Shire, filed for use in pediatric and surgical settings in the U.S.
On Monday, the FDA said it was fast-tracking its review of Shire’s experimental midstage fatty liver disease drug volixibat as the competition heats up to be the first to market in that arena. The drug is designed to treat nonalcoholic steatohepatitis (NASH) with liver fibrosis, which is a condition that affects millions of Americans and has been shown to be a direct link to the increase of obesity and type II diabetes.
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