Shire gains US approval for Baxalta's improved Baxject haemophilia system

Shire has received US regulatory approval for an improved haemophilia-A treatment developed by recently acquired Baxalta.

The US Food and Drug Administration (FDA) approved the Baxject III reconstitution system for Adynovate, a new preparation for the recombinant antihemophilic which reduces the number of steps in the reconstitution process for hemophilia A patients and caregivers.

Adynovate and the diluent will be pre-packaged in the Baxject III reconstitution system when it is made available to customers in the fourth quarter of the year.

“At Shire our focus is always on the patient, so we're pleased to provide our hemophilia A patients with a new option that will enable them to prepare their treatment with fewer steps,” said Perry Sternberg, Shire's head of US commercial.

“Streamlining the process may minimize opportunities for reconstitution errors, helping to ensure patients can get the full benefit of their treatment.”

The new system reduces the number of steps in the treatment process by two, compared to the previous process with the Baxject II Hi Flow Needleless transfer device.