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CSL Behring passes US FDA's approval for IDELVION in new 3500 IU Vial for treating hemophilia B.

M2 EQUITYBITES-June 1, 2018-CSL Behring passes US FDA's approval for IDELVION in new 3500 IU Vial for treating hemophilia B


Biotherapeutics company CSL Behring revealed on Thursday that it has passed the US Food and Drug Administration's (FDA) approval for 3500 IU vial size for IDELVION, Albumin Fusion Protein (rFIX-FP)] for treating hemophilia B.

Hemophilia B is a congenital bleeding disorder characterised by deficient or defective factor IX; nearly all affected patients are male. People with hemophilia B may experience prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs.

Under the company's 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.

The company added the US FDA has approved 3500 IU (international unit) vial size for IDELVION [Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP)] for treating hemophilia B.

However, for 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, according to the company.

IDELVION, the company's novel, long-acting recombinant albumin fusion protein, is an factor IX therapy that delivers zero median AsBR (annualised spontaneous bleeding rate) and is approved for up to 14-day dosing in appropriate patients. It has been shown to elevate factor IX levels to 21% at steady state.

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Publication:M2 EquityBites (EQB)
Date:Jun 1, 2018
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