October Rx Product News

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 aged 6 years or older with active psoriatic arthritis (PsA). Ustekinumab is the first biologic that targets cytokines IL-12 and IL-23, which are thought to affect overacting inflammatory response in several autoimmune diseases. The drug is administered subcutaneously 4 times a year following 2 started doses for patients with active PsA. The approval is based on pharmacokinetic data and extrapolation of the established efficacy and safety profile of ustekinumab in several phase 3 trials. The trials included CADMUS (NCT01090427), CADMUS Jr (NCT02698475), PSTELLAR (NCT01550744), PSUMMIT/PSUMMIT II (NCT01009086).

For More Information:

jnj.com

Upadacitinib (Rinvoq)

Manufactured by AbbVie

AbbVie has submitted upadacitinib (Rinvoq) for a new indication, which will include the treatment of individuals with moderately to severely active Crohn disease, to the European Medicines Agency and the FDA. The application is supported by 3 phase 3 clinical trials, including 2 induction studies, U-EXCEED (NCT03345836) and U-EXCEL (NCT03345849), and 1 maintenance study, U-ENDURE (NCT03345823). Individuals were given upadacitinib 45 mg once daily as an induction therapy and upadacitinib at either 15 or 35 mg once daily as a maintenance therapy. Across all 3 studies, investigators found that a significantly higher number of individuals treated with the drug achieved the coprimary end points of clinical remission and endoscopic response. Additionally, they found that more individuals had a clinical remission measured by the Crohn Disease Activity Index by patient-reported symptoms of abdominal pain and stool frequency. The safety results across all 3 studies were generally consistent with the known safety profile of upadacitinib, and no new safety signals were observed.

For More Information:

abbvie.com

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 hemophilia B related bleeding. In 2017, coagulation factor IX (recombinant) GlycoPEGylated was approved as an extended half-life treatment used to replace clotting factor IX for on-demand treatment and control of bleeding episodes. The new indication is for prevention of bleeding and to reduce the risk of bleeding. Study results showed that adults and adolescents who were previously treated and taking coagulation factor IX (recombinant) GlycoPEGylated40 IU/kg once weekly for 1 year experienced an overall median annualized bleeding rate of 1.04, with zero observed inhibitors or thrombotic episodes.

For More Information:

novonordisk-us.com

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 an adjunctive therapy for individuals with epilepsy 16 years or older who suffer from partial seizures. It is the first FDA approved oral liquid formation of zonisamide in the 100 mg/5 mL dosage, which helps individuals with epilepsy who have difficulty swallowing tablets. The drug was approved following 3 double-blind, multicenter, placebo-controlled trials, which found it to be effective and tolerated by patients. It was approved to be prescribed at 1 to 2 doses daily.

For More Information:

etonpharma.com