This month's featured products include treatments for insomnia, atopic dermatitis, and more.
Manufactured by Idorsia Pharmaceuticals
The FDA has approved daridorexant for the treatment of individuals with insomnia. Daridorexant is a dual orexin receptor antagonist that blocks the binding of orexins; these wake-promoting neuropeptides are connected to sleep/wake regulation. The drug is thought to reduce overactive wakefulness as opposed to sedating the brain, according to Idorsia Pharmaceuticals. The approval was for the 25- and 50-mg doses and is based on an extensive clinical program that included 1854 individuals with insomnia at more than 160 clinical trial sites across 18 countries. The most common adverse events were headache and somnolence or fatigue. The FDA recommended that daridorexant be classified as a controlled substance, and the drug is expected to be available in May 2022 following scheduling by the US Drug Enforcement Administration.
For more information: idorsia.com
Manufactured by Novartis
Inclisiran has become the first small interfering RNA therapy to be approved by the FDA. It is intended to reduce low-density lipoprotein cholesterol (LDL-C) with 2 doses per year, following an initial dose and a dose at 3 months. Inclisiran is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia who require additional lowering of LDL-C. The FDA approval is based on data from the comprehensive phase 3 ORION-9, -10, and -11 trials, in which all 3457 individuals with ASCVD or heterozygous familial hypercholesterolemia had elevated LDL-C while receiving a maximally tolerated dose of statin therapy. At month 17, inclisiran delivered effective and sustained LDL-C reduction of up to 52% compared with the placebo. The most common adverse effects were diarrhea, mild to moderate injection site reactions, pain, shortness of breath, and urinary tract infections.
For more information: novartis.com
Manufactured by LEO Pharma
The FDA has approved tralokinumab-ldrm for the treatment of moderate to severe atopic dermatitis (AD) for adults with disease not well controlled with topical prescription therapies or for whom those therapies are not advisable. It can be used with or without a topical corticosteroid. The drug is an injection and is the first and only FDA-approved biologic that binds to and inhibits the IL-13 cytokine, a key driver of AD signs and symptoms. The approval is based on efficacy and safety results from the ECZTRA 1, ECZTRA 2, and ECZTRA 3 phase 3 trials. The studies included nearly 2000 individuals with moderate to severe AD. Serious adverse events (AEs) include breathing and eye problems, hives, hypotension, itching, skin rashes, and swelling of the face, mouth, and tongue. Other common AEs include eosinophilia, eye and eyelid inflammation, and injection site reactions.
Manufactured by Xeris Biopharma Holdings
The FDA has approved levoketoconazole for the treatment of endogenous hypercortisolemia for adults with Cushing syndrome for whom surgery has not been curative or is not an option. Levoketoconazole is a cortisol synthesis inhibitor and received an orphan drug designation from the FDA. Endogenous Cushing syndrome is a potentially fatal but rare endocrine disease caused by chronic elevated cortisol exposure, often resulting from a benign tumor of the pituitary gland. The approval is based on efficacy and safety data from 2 positive phase 3 studies that evaluated a combined study population of 166 individuals, which represented the US population with Cushing syndrome. Common adverse events were abnormal uterine bleeding, contusions, fatigue, headaches, hemorrhages, hypokalemia, nausea, systemic hypertension, and vomiting.
For more information: xerispharma.com