Aptevo Therapeutics announced the launch of its new vial size for its coagulation factor IX recombinant (Ixinity) treatment for hemophilia B in the US market.
Aptevo Therapeutics has announced the launch of its new vial size for its coagulation factor IX recombinant (Ixinity) treatment for hemophilia B in the US market, according to a press release.
Ixinity is an intravenous recombinant factor IX therapeutic indicated for the control and prevention of bleeding episodes and for perioperative management in adults and children 12 years of age and older with hemophilia B.
Hemophilia B, a congenital bleeding disorder characterized by a deficiency of coagulation factor IX, affects approximately 4000 individuals in the United States. The disorder may result in spontaneous or trauma-induced bleeding into joints, muscles, and soft tissues, which can lead to joint damage, reduction in mobility, and severe arthritis.
The new and larger 3000 international unit (IU) assay for the product offers enhanced convenience for patients, according to Aptevo. The product is also available in 3 other assay sizes: -500 IU, 1000 IU, and 1500 IU.
In a statement, Mike Adelman, senior vice president of commercial operations for Aptevo, noted that, depending on the patient’s dose, the larger assay sizes require less time to reconstitute the product for infusion and decreases overall infusion time. This can be especially beneficial for patients with severe hemophilia who require higher doses.
“Moreover, larger assays also require fewer vials for dosing, equating to improved convenience for storage and travel,” Adelman added. “Higher IU assays also provide improved value for our channel partners due to the requirement for less storage space and the potential for reduced shipping expenses.”
Although currently approved for use in patients 12 years of age and older, Aptevo is expected to begin a phase 4 study testing Ixinity for potential label expansion in a pediatric setting.
With the new vial size, patients with hemophilia B are given another option with the potential for reduced reconstitution time and infusion volume, according to the release.
Aptevo Therapeutics Launches New 3000 IU Ixinity Assay Offering Enhanced User Experience and Improved Convenience for Hemophilia B Patients [news release]. Aptevo Therapeutics. https://aptevotherapeutics.gcs-web.com/news-releases/news-release-details/aptevo-therapeutics-launches-new-3000-iu-ixinity-assay-offering. Accessed July 1, 2019.