Rx Product News: August 2022

Risankizumab-rzaa (Skyrizi)

Manufactured by AbbVie

The FDA has approved risankizumab-rzaa (Skyrizi) for the treatment of adults with moderately to severely active Crohn disease. Risankizumab-rzaa is a humanized immunoglobulin G1 monoclonal antibody that selectively binds to the p19 subunit of the IL-23 cytokine and inhibits its interaction with the IL-23 receptor. Dosing for risankizumab-rzaa is 600 mg administered by intravenous infusion over at least 1 hour at weeks 0, 4, and 8, followed by 360 mg self-administered by subcutaneous injection with an on-body injector at week 12 and every 8 weeks thereafter. The approval makes risankizumab-rzaa the only specific IL-23 inhibitor for this indication.

FOR MORE INFORMATION:

abbvie.com

Relugolix, Estradiol, and Norethindrone Acetate (Myfembree)

Manufactured by: Myovant Sciences, Pfizer

The FDA has accepted a supplemental new drug application (sNDA) for relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg (Myfembree; Myovant Sciences, Pfizer) for review. The acceptance of the sNDA proposes updates to the United States Prescribing Information based on data from the phase 3 LIBERTY randomized withdrawal study (NCT03412890). The study included individuals who were premenopausal with heavy menstrual bleeding associated with uterine fibroids for up to 2 years. The FDA has an action date of January 29, 2023. The most common adverse events were alopecia, decreased libido, hot flushes, hyperhidrosis, and uterine bleeding.

FOR MORE INFORMATION:

myfembree.com

Baricitinib (Olumiant)

Manufactured by: Eli Lilly and Company

The FDA has approved baricitinib (Olumiant; Eli Lilly and Company) tablets for the treatment of adults with severe alopecia areata. The approval marks the first systemic treatment to be given the green light by the FDA for this condition. Baricitinib was also previously granted priority review and breakthrough therapy designation for this indication. The most common adverse effects are abdominal pain, acne, anemia, Candida infections, elevated liver enyzmes, folliculitis, headaches, herpes zoster, hyperlipidemia, increased creatinine phosphokinase, lower respiratory tract infections, nausea, neutropenia, upper respiratory tract infections, urinary tract infections, and weight gain.

FOR MORE INFORMATION:

lilly.com

Dupilumab (Dupixent)

Manufactured by Regeneron Pharmaceuticals

The FDA has approved dupilumab (Dupixent; Regeneron Pharmaceuticals) injectable for the treatment of children aged 6 months to 5 years with moderate to severe atopic dermatitis (AD) whose disease is not controlled with topical prescription therapies or for when those therapies are not advisable. Approval in this patient population makes dupilumab the only biologic medicine approved for the treatment of moderate to severe AD from infancy through adulthood. The safety profile was generally consistent with the known profile for individuals 6 years or older. Additionally, the long-term safety profile was consistent with older individuals with AD.

FOR MORE INFORMATION:

regeneron.com