FDA Approvals Roundup: Ryaltris, Cibinqo, Rinvoq
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).New approvals
Ryaltris okayed for seasonal allergic rhinitis
Glenmark’s Ryaltris (olopatadine and mometasone furoate; nasal spray) has been approved for seasonal allergic rhinitis in adults and pediatric patients aged 12 years or older.
The approval of Ryaltris was based on findings from two multicenter, randomized, double-blind, placebo-and active-controlled clinical studies (Study 1 and Study 2) in a total of 2,356 patients from the indicated population. After a two-week treatment period, patients receiving Ryaltris showed a statistically significant improvement in the patient-reported total nasal symptom score compared with those receiving olopatadine hydrochloride alone, mometasone furoate alone, or placebo.
Hikma Specialty will market and distribute Ryaltris in the US as part of an exclusive licensing agreement with Switzerland-based Glenmark.
Cibinqo approved for atopic dermatitis for adults
Pfizer’s Cibinqo (abrocitinib; tablets) has been approved for treating refractory, moderate-to-severe atopic dermatitis in adults.
Cibinqo’s approval was based on findings from five clinical trials, including the JADE Mono-1, JADE Mono-2, and JADE Compare trials, in more 1,615 patients from the indicated population. Across the trials, Cibinqo demonstrated a consistent safety profile and improvements from baseline in skin clearance, extent of disease, and disease severity, as well as rapid improvement in itch after two weeks, compared with placebo. In addition, a higher proportion of patients receiving Cibinqo in the two monotherapy trials achieved improvement in itching at week 12 compared with placebo.
Cibinqo comes with a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
New indications
Rinvoq gets new indication for difficult-to-treat atopic dermatitis
AbbVie’s Rinvoq (upadacitinib; tablets) has been granted a new indication for treating moderate-to-severe atopic dermatitis in adults and children 12 years of age and older who have not responded to previous treatment and whose disease is not well controlled.
The approval of Rinvoq was based on findings from three Phase 3 randomized, double-blind, multicenter trials (Measure Up 1 and Measure Up 2, and AD Up) in 2,584 patients from the indicated population who received once-daily Rinvoq 15 or 30 mg or placebo for 16 weeks. Patients in the AD Up study received Rinvoq or placebo with concomitant topical corticosteroids. Findings from all three trials showed improvements from baseline in itch, skin clearance, and disease severity with Rinvoq compared with placebo.
Rinvoq, selective JAK inhibitor, was originally approved in 2019 for treating adults with rheumatoid arthritis. It is also approved for treating psoriatic arthritis. The therapy comes with a boxed warning for serious infections, malignancy, and thrombosis.
