CSL Behring issued the following announcement on May 31.
Global biotherapeutics leader CSL Behring today announced that the US Food and Drug Administration (FDA) has approved a 3500 IU (international unit) vial size for IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP)], its novel, long-acting recombinant albumin fusion protein for treating hemophilia B. For some patients requiring high doses of IDELVION, the 3500 IU vial size will reduce the reconstitution time needed to prepare multiple vials for a similar dose. IDELVION is the first and only FDA-approved factor IX therapy that delivers zero median AsBR (annualized spontaneous bleeding rate) and is approved for up to 14-day dosing in appropriate patients. When used prophylactically, IDELVION has been shown to elevate factor IX levels to 21% at steady state.
“Having a variety of vial sizes available for patients, particularly larger vials, increases convenience for patients in optimizing their administration regimen,” said Craig Kessler, MD, Director, Division of Coagulation and Director of the Hemophilia and Thrombosis Comprehensive Care Center, Georgetown University Medical Center. “The 3500 IU vial can be helpful for patients currently on IDELVION or those who might have been waiting until more convenient vial sizes were available in order to begin treatment with IDELVION.”
“We believe a good portion of the community will benefit from the addition of this fifth, larger vial to the IDELVION family,” adds Jerry Powell, MD, Coagulation Medical Director, North America, CSL Behring. “Reconstituting the same amount of factor from a single vial will require less diluent than reconstituting multiple vial sizes, saving patients time and ancillary supplies.”
In the clinical trial, IDELVION delivered high factor IX levels of 21% at steady state with prophylactic use and 5% over 14 days with one single dose. IDELVION is currently available in 250 IU, 500 IU, 1000 IU, and 2000 IU, with the 3500 IU vial to be available for order in the coming weeks.
Original source can be found here.