RECENT FDA APPROVALS continued

Drug Name Manufacturer

sparsentan (Filspari™) Travere antihemophilic

Bioverativ

Description

New Drugs continued

• NDA approval 02/17/2023; Accelerated Approval, Orphan Drug, Priority Review

• Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine proteinto-creatinine ratio (UPCR) ≥ 1.5 g/g

• Accelerated Approval based on reduction in proteinuria; the effect of sparsentan on kidney function decline is unknown; continued approval for this use may require demonstration of benefit in confirmatory clinical trials

• Endothelin and angiotensin II receptor antagonist

• Oral tablet: 200 mg, 400 mg

• Recommended starting dosage is 200 mg once daily; after 14 days, the dose should be increased to 400 mg once daily, if tolerated; swallow whole with water before the morning or evening meal; measure aminotransferase levels and total bilirubin prior to initiating therapy and monitor monthly for the first 12 months, then every 3 months; dosage adjustments may be required due to aminotransferase elevations

• Boxed warnings for hepatotoxicity and embryo-fetal toxicity; only available through a REMS program

• BLA approval 02/22/2023; Breakthrough Therapy, Fast Track, Orphan Drug, Priority Review

• Indicated for use in adults and pediatric patients with hemophilia A (congenital factor VIII deficiency) for (1) routine prophylaxis to reduce the frequency of bleeding episodes; (2) on-demand treatment and control of bleeding episodes; and (3) perioperative management of bleeding

• Not indicated for the treatment of von Willebrand disease

• Recombinant DNA-derived, factor VIII concentrate

• For injection: 250 IU, 500 IU, 750 IU, 1,000 IU, 2,000 IU, 3,000 IU, or 4,000 IU of lyophilized powder in an SDV for reconstitution

• Recommended dosage is 50 IU/kg IV once weekly for routine prophylaxis and 50 IU/kg once, followed by 30 or 50 IU/kg doses, if needed, every 2 to 3 days depending on severity of bleeding (on-demand indication) or type of surgery; patient or caregiver can administer following proper training

• Product availability is expected in April 2023

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