Specialty Drugs: Year in Review 2017 Part I

The year 2017 was another in which specialty pharmaceuticals featured prominently in the actions of the FDA. Below is the first installment of a summary of specialty pharmacy–related FDA approvals and expanded indications that took place in 2017. The second installment will include oncology drugs and late-breaking FDA actions. Please consult product prescribing monographs for complete information including dosing regimens.

 

Bleeding Disorders

On May 31, 2017, the FDA approved Rebinyn (coagulation factor IX [recombinant], glycopegylated) for the treatment of adults and children with hemophilia B for on-demand treatment and control of bleeding episodes and perioperative management of bleeding. Rebinyn is not indicated for routine prophylaxis in the treatment of patients with hemophilia B or immune tolerance induction in patients with hemophilia B.  Rebinyn glycopegylated is an extended–half-life recombinant DNA-derived coagulation factor IX concentrate. Rebinyn is available as a lyophilized powder in single-use vials of 500, 1000, and 2000 international units (IU) of factor IX potency per vial with a MixPro prefilled diluent syringe containing histidine solution and a sterile vial adapter for intravenous (IV) infusion. Dosage and duration of treatment with Rebinyn depend on the severity of factor IX deficiency, the location and extent of bleeding, and the patient’s clinical condition, body weight, and recovery of factor IX.1,2
 

Inflammatory Conditions

On February 15, 2017, Siliq (brodalumab) received FDA approval for treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and have failed to respond or lost response to other systemic therapies. Siliq is a human interleukin-17 receptor A antagonist that is available in a single prefilled syringe (PFS) containing 210 mg/1.5 mL solution for subcutaneous (SC) injection. The recommended dosage is 210 mg of Siliq by SC injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks. Treatment beyond 16 weeks in patients who have not achieved an adequate response is not likely to result in greater success. Siliq is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS)—called the Siliq REMS Program—because of the boxed warning of suicidal ideation and behavior associated with the medication.3,4

On March 28, 2017, Dupixent (dupilumab) received FDA approval for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The FDA granted the application for Dupixent both Priority Review and Breakthrough Therapy designation. Dupixent can be used with or without topical corticosteroids. The interleukin-4 receptor alpha antagonist is available in a solution of 300 mg/2 mL in a single-dose PFS with a needle shield for SC use. The recommended initial dose is 600 mg (two 300-mg injections in different injection sites), followed by 300 mg every other week. The safety and efficacy of Dupixent has not been established in the treatment of asthma.5,6

On March 30, 2017, Humira (adalimumab) received an approved labeling revision to include data regarding moderate-to-severe fingernail psoriasis in the Humira prescribing information for patients with moderate-to-severe chronic plaque psoriasis. Humira, a tumor necrosis factor (TNF) blocker, was originally approved on December 31, 2002, for the treatment of rheumatoid arthritis. It has since received indications for juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease in adult and pediatric patients 6 years and older, adult ulcerative colitis, plaque psoriasis, uveitis, and moderate-to-severe hidradenitis suppurativa.7,8

On April 21, 2017, Renflexis (infliximab-abda) was approved by the FDA as the second available biosimilar to Remicade (infliximab). Renflexis is indicated for the treatment of adult and pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis in combination with methotrexate, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. The TNF blocker is available in a 100-mg single-dose vial of lyophilized powder of infliximab-abda for a final reconstitution volume of 10 mL. Renflexis is administered via IV infusion over a period of not less than 2 hours.9,10

On May 22, 2017, Kevzara (sarilumab) was approved by the FDA for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to 1 or more disease-modifying antirheumatic drugs (DMARDs). The interleukin-6 receptor antagonist is available as a solution of 150 mg/1.14 mL or 200 mg/1.14 mL in a single-dose PFS for SC administration.  The recommended dose of Kevzara is 200 mg once every 2 weeks. Kevzara may be used as monotherapy or in combination with methotrexate or other conventional DMARDs.11,12

On May 22, 2017, Actemra (tocilizumab) received an expanded indication for the treatment of adults with giant cell arteritis. The FDA granted this application Breakthrough Therapy designation and Priority Review. Furthermore, on August 30, 2017, Actemra received an expanded indication for the treatment of adults and pediatric patients 2 years and older with chimeric antigen receptor T cell–induced severe or life-threatening cytokine release syndrome (CRS). The FDA granted Priority Review and Orphan Drug designation to Actemra for this indication. Actemra is an interleukin-6 receptor antagonist that was originally approved in January 2010. Actemra is also indicated in the treatment of adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response to 1 or more DMARDs and patients 2 years and older with active juvenile idiopathic arthritis. Actemra is available in single-use vials of 20 mg/mL for IV administration and a single-use PFS providing 162 mg of Actemra in 0.9 mL for SC administration. The recommended dose of Actemra for adult patients with giant cell arteritis is 162 mg administered once weekly as an SC injection, in combination with a tapering course of glucocorticoids. A dose of 162 mg administered once every other week as a SC injection, in combination with a tapering course of glucocorticoids, may be prescribed based on clinical considerations. The recommended dose of Actemra for CRS is 12 mg/kg IV (<30 kg) or 8 mg/kg (≥30 kg), alone or in combination with corticosteroids, as a 60-minute IV infusion. If no clinical improvement in the signs and symptoms of CRS occurs after the first dose, up to 3 additional doses of Actemra may be administered. The interval between consecutive doses should be at least 8 hours. SC administration is not approved for CRS.13-15

On July 6, 2017, Orencia (abatacept) received an expanded FDA indication for the treatment of active psoriatic arthritis in adult patients by IV or SC administration. Orencia is a selective T-cell co-stimulation modulator that was originally approved in December 2005. Orencia is also indicated for the treatment of moderately to severely active rheumatoid arthritis in adults and juvenile idiopathic arthritis in patients 2 years and older. Orencia may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. Orencia is available in a single-use vial containing 250 mg lyophilized powder for IV infusion. Orencia is also available in a solution of 50 mg/0.4 mL, 87.5 mg/0.7 mL, and 125 mg/mL in a single-dose PFS and a solution of 125 mg/mL in a single-dose prefilled ClickJect autoinjector for SC use. The recommended dose of Orencia IV for patients with psoriatic arthritis is dependent on the patient’s weight and is administered as a 30-minute IV infusion. Following the initial IV administration, the next IV infusion should be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter. The recommended dose of Orencia SC for psoriatic arthritis patients is 125 mg once weekly without the need for an IV loading dose.16,17 

On July 13, 2017, Tremfya (guselkumab) was approved by the FDA for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Tremfya is an interleukin-23 blocker that is available in a single-dose PFS of 100 mg/mL. The recommended dose of Tremfya is 100 mg SC at week 0 and week 4 and every 8 weeks thereafter.18,19

On July 21, 2017, Benlysta (belimumab) was approved for a new SC formulation for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. Benlysta is a B lymphocyte stimulator-specific inhibitor that was first approved in March 2011 for the treatment of SLE via IV administration. Benlysta is now available in a single-dose prefilled autoinjector of 200 mg/mL or single-dose PFS for SC administration. The recommended dose of Benlysta for SC administration is 200 mg once weekly.20,21 

On August 25, 2017, Cyltezo (adalimumab-adbm) received FDA approval for the treatment of various inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, juvenile idiopathic arthritis, and plaque psoriasis. The TNF blocker is the second available biosimilar to Humira. Cyltezo is available as a single-use glass PFS of 40 mg/0.8 mL.22,23
 

HIV

On May 30, 2017, Isentress (raltegravir) was approved for a new dosing option. Isentress HD is a 1200-mg once-daily dose administered orally as two 600-mg film-coated tablets, with or without food, in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg who are treatment-naïve or whose virus has been suppressed on an initial regimen of Isentress 400 mg administered twice daily. The coadministration of Isentress HD with aluminum- and/or magnesium-containing antacids and calcium carbonate antacids is not recommended.  Isentress was originally approved in October 2007 for the treatment of HIV-1 infection in combination with other antiretroviral agents.24,25 
 



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