FDA Roundup: First 1-Year CGM, Lebrikizumab-lbkz for Atopic Dermatitis

FDA Clears First 1-Year CGM for Diabetes

The FDA has given clearance to the continuous glucose monitor (CGM) Eversense 365 for adult patients with type 1 and type 2 diabetes, Senseonics and Ascensia Diabetes Care announced in a release. Ascensia said that it anticipates a launch of the product to occur in the United States in the fourth quarter of this year.

The Eversense 365 is the world’s first long-term CGM that provides patients with 1 year of use. The fully-implantable device allows for minimal life disruption compared to short-term CGMs, which typically last around 10 to 14 days. The CGMs 12-month survivability also reduces data interruptions that occur with shorter lasting devices due to sensor failures or changes.

FDA Approves Lebrikizumab-lbkz for Moderate-to-Severe Atopic Dermatitis

The FDA has approved Eli Lilly and Company’s lebrikizumab-lbkz (Ebglyss), a targeted IL-13 inhibitor for the treatment of moderate-to-severe atopic dermatitis that is not well controlled by topical prescription therapies in adults and children 12 years of age and older who weigh at least 88 pounds, the company announced in a release.

Lebrikizumab-lbks injection can be used with or without topical corticosteroids. After an initial treatment phase, it is dosed as a single monthly maintenance injection. The recommended starting dose is 500 mg, administered as two 250 mg injections at week 0 and 2, followed by 250 mg injections every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is administered as a single 250 mg monthly injection every 4 weeks.

FDA Approves Benralizumab for Eosinophilic Granulomatosis with Polyangiitis

The FDA has approved benralizumab (Fasenra) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in adult patients, AstraZeneca announced in a release. The decision makes the therapy the second approved to treat the rare disease in the United States, with the other being GSK’s mepolizumab (Nucala).

The approval of benralizumab was based on data from the phase 3 MANDARA (NCT04157348) trial, in which the therapy met the primary endpoint of proportion of patients in remission at both weeks 36 and 48. Benralizumab also met its secondary endpoint of proportion of patients able to fully taper off of oral corticosteroids at weeks 48 through 52. Data from the study was published in The New England Journal of Medicine.

Ribociclib Plus Aromatase Inhibitor Approved as Adjuvant Therapy for HR+/HER2- Early Breast Cancer

The FDA has approved ribociclib (Kisqali) in combination with an aromatase inhibitor as an adjuvant treatment for individuals with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage 2 and stage 3 early breast cancer, who are at high risk of recurrence—including those with node-negative disease.

Approval followed results of the NATALEE clinical trial (NCT03701334), a pivotal phase 3, multicenter, randomized, open-label clinical trial evaluating the efficacy and safety of ribociclib plus endocrine therapy as an investigational adjuvant therapy vs endocrine therapy alone in this patient population. Data from NATALEE were presented at the American Society of Clinical Oncology Annual Meeting in June 2024 and at the San Antonio Breast Cancer Symposium in December 2023. Results were published in the New England Journal of Medicine earlier this year.

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