Specialty Drugs: Year in Review 2016, Part I

This year was another in which specialty pharmaceuticals featured prominently in the actions of the FDA.

Although there were not as many new specialty drug approvals to date in 2016, there were many already-approved specialty medications that received expanded indications. Below is the first installment of a summary of specialty pharmacy-related FDA approvals and expanded indications that took place in 2016.

The next installment, part II, will include oncology drugs, as well as late-breaking FDA actions. Please consult the product prescribing monographs for complete information including dosing regimens.

Bleeding Disorders
On March 4, 2016, the FDA approved Idelvion (coagulation factor IX [recombinant]), albumin fusion protein (rIX-FP), CSL Behring) in children and adults with hemophilia B (congenital factor IX deficiency) for on-demand control and prevention of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Idelvion is not indicated for immune tolerance induction in patients with hemophilia B. The drug is a recombinant coagulation factor IX protein with an extended half-life, developed through fusion with recombinant albumin for a longer duration of action. Idelvion is administered as an intravenous infusion. It is available as a lyophilized powder in single-use vials containing nominally 250, 500, 1000, or 2000 international units (IU) of factor IX activity per vial, packaged with sterile water for injection, USP for reconstitution, 1 Mix2Vial filter transfer set, and 1 sterile alcohol swab. Dosage and duration of treatment with Idelvion depends on the severity of factor IX deficiency, the location and extent of bleeding, and the patient’s clinical condition, age, and recovery of factor IX.1,2

On March 17, 2016, Kovaltry (antihemophilic factor [recombinant]) was approved in adults and children with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes. Kovaltry is a recombinant, human DNA sequence derived, full length factor VIII concentrate.

Kovaltry is not indicated for the treatment of von Willebrand disease. Kovaltry is available as lyophilized powder in single-use vials containing nominally 250, 500, 1000, 2000, or 3000 IU of recombinant factor VIII per vial. Dosage and duration of treatment depends on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition.3,4

On May 25, 2016, Afstyla (antihemophilic factor [recombinant], Single Chain) was approved for adults and children with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes; routine prophylaxis to reduce the frequency of bleeding episodes; and perioperative management of bleeding. Afstyla is not indicated for the treatment of von Willebrand disease.

Afstyla is available as a lyophilized powder in single-use vials containing nominally 250, 500, 1000, 2000, or 3000 IU. Dosage and duration of treatment depends on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition.5,6



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