Cibinqo (abrocitinib) for Refractory, Moderate to Severe Atopic Dermatitis
The Food and Drug Administration (FDA) approved Cibinqo, an oral Janus kinase 1 inhibitor, for the treatment of refractory, moderate to severe atopic dermatitis in adults whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. The approval was based on data from the phase 3 JADE clinical trial program. Compared with placebo, a significantly greater proportion of patients treated with Cibinqo met the coprimary endpoints: Investigator’s Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of at least 2 points; and 75% improvement from baseline on the Eczema Area and Severity Index (EASI) at week 12.
Kimmtrak (tebentafusp-tebn) for Unresectable or Metastatic Uveal Melanoma
Kimmtrak is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. It is the first treatment approved for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. The approval was based on data from the phase 2 IMCgp100-202 trial. Results showed that treatment with Kimmtrak was associated with a clinically and statistically meaningful overall survival benefit (hazard ratio [HR] 0.51; 95% CI, 0.37-0.71; P <.0001) compared with the investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). Kimmtrak is administered intravenously.
Quviviq (daridorexant) for the Treatment of Insomnia
Quviviq, a dual orexin receptor antagonist, was approved for adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. The approval was based on data from a comprehensive development program that included 2 pivotal phase 3 studies. Findings showed that Quviviq demonstrated statistically significant and clinically meaningful improvements in sleep onset, sleep maintenance, and patient reported total sleep time. The product was not associated with next morning residual effects, rebound insomnia, or withdrawal symptoms upon discontinuation. Quviviq is expected to be available following scheduling by the US Drug Enforcement Administration.
Recorlev (levoketoconazole) for Cushing Syndrome
Recorlev is a cortisol synthesis inhibitor approved for the treatment of endogenous hypercortisolemia in adults with Cushing syndrome for whom surgery is not an option or has not been curative. Approval of the oral therapy was based on data from the phase 3 SONICS and LOGICS studies. Findings from both trials showed that patients treated with Recorlev achieved a significant reduction and normalization of mean urinary free cortisol. Recorlev was also associated with statistically significant and clinically meaningful improvements from baseline in fasting blood glucose, hemoglobin A1C, total cholesterol, low density lipoprotein cholesterol, body weight and body mass index.
Vabysmo (faricimab-svoa) for Wet AMD, Diabetic Macular Edema
Vabysmo is a humanized bispecific antibody that works by inhibiting the angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) pathways. It is the first bispecific antibody approved for the eye. The product received FDA approval for the treatment of wet, or neovascular, age-related macular degeneration and diabetic macular edema based on data from four phase 3 trials. Findings demonstrated that patients who received intravitreal injections with Vabysmo at intervals of up to 4 months achieved noninferior vision gains compared with aflibercept.
- Cibinqo. Package insert. Pfizer; 2021. Accessed February 2, 2022. https://cdn.pfizer.com/pfizercom/USPI_Med_Guide_CIBINQO_Abrocitinib_tablet.pdf
- Kimmtrak. Package insert. Immunocore Holdings Limited; 2021. Accessed February 2, 2022. https://ir.immunocore.com/static-files/4e58e85c-de58-4b36-8076-f14cf1cbe206
- Quviviq. Package insert. Idorsia Pharmaceuticals Ltd; 2021. Accessed February 2, 2022. https://www.idorsia.us/documents/us/label/Quviviq_PI.pdf
- Recorlev. Package insert. Xeris Biopharma; 2021. Accessed February 2, 2022. https://www.recorlev.com/full-prescribing-information.pdf
- Vabysmo. Package insert. Genentech; 2021. Accessed February 2, 2022. https://www.gene.com/download/pdf/vabysmo_prescribing.pdf