October Rx new products

Keep an eye out for this month’s latest news on Rx products.

Ustekinumab (Stelara)

Manufactured by Johnson and Johnson

The FDA has approved ustekinumab (Stelara; Janssen Pharmaceutical Companies of Johnson and Johnson) for the treatment of children ages 6 and older with active psoriatic arthritis (PsA). Ustekinumab is the first biologic to target the cytokines IL-12 and IL-23, which are thought to affect the excessive inflammatory response in several autoimmune diseases. The drug is administered subcutaneously in patients with active PsA 4 times a year after 2 initial doses. The approval is based on pharmacokinetic data and extrapolation of the established efficacy and safety profile of ustekinumab in multiple phase 3 studies. Studies included CADMUS (NCT01090427), CADMUS Jr (NCT02698475), PSTELLAR (NCT01550744), PSUMMIT/PSUMMIT II (NCT01009086).

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Upadacitinib (Rinvoq)

Manufactured by AbbVie

AbbVie has submitted upadacitinib (Rinvoq) to the European Medicines Agency and the FDA for a new indication that will include the treatment of people with moderately to severely active Crohn’s disease. The application is supported by 3 phase 3 clinical studies, including 2 induction studies, U-EXCEED (NCT03345836) and U-EXCEL (NCT03345849), and 1 maintenance study, U-ENDURE (NCT03345823). Patients received upadacitinib 45 mg once daily for induction therapy and either 15 or 35 mg upadacitinib once daily for maintenance therapy. In all 3 studies, researchers found that a significantly higher number of people treated with the drug achieved the co-primary endpoints of clinical remission and endoscopic response. In addition, they found that more people were in clinical remission as measured by Crohn’s disease activity index based on patient-reported symptoms of abdominal pain and stool frequency. The safety results from all 3 studies were generally consistent with the known safety profile of upadacitinib and no new safety signals were observed.

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Coagulation Factor IX (recombinant) GlycoPEGylated (Rebinyn)

Manufactured by: Novo Nordisk

The FDA has approved coagulation factor IX (recombinant) GlycoPEGylated (Rebinyn; Novo Nordisk) for routine prophylaxis in adults and children to prevent bleeding associated with hemophilia B. In 2017, coagulation factor IX (recombinant) GlycoPEGylated was approved as an extended half-life treatment to be used as a replacement for coagulation factor IX for on-demand treatment and control of bleeding episodes. The new indication serves to prevent bleeding and reduce the risk of bleeding. Study results showed that previously treated adults and adolescents taking coagulation factor IX (recombinant) GlycoPEGylated 40 IU/kg once weekly for 1 year had a median annualized total bleeding rate of 1.04 with no observed inhibitors or thrombotic episodes .

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Zonisamide oral suspension (Zonisade)

Manufactured by Azurity Pharmaceuticals and Eton Pharmaceuticals, Inc

The FDA approved zonisamide oral suspension (Zonisade; Azurity Pharmaceuticals and Eton Pharmaceuticals, Inc) as add-on therapy for people 16 years and older with epilepsy and partial-onset seizures. It is the first FDA-approved oral liquid formulation of zonisamide at a dosage of 100 mg/5 mL to help people with epilepsy who have difficulty swallowing pills. The drug was approved after 3 double-blind, multi-center, placebo-controlled studies that proved effective and well-tolerated by patients. It has been approved to be prescribed in 1 to 2 doses daily.

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