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Monthly News Roundup - July 2024

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on July 31, 2024.

Lilly’s Kisunla Approved to Treat Early Symptomatic Alzheimer's Disease

In July, the FDA cleared Eli Lilly’s Kisunla (donanemab-azbt), an amyloid beta-directed monoclonal antibody indicated for the treatment of early symptomatic Alzheimer’s disease. Kisunla is given as a once-monthly IV infusion. Treatment with Kisunla should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in studies.

FDA Approves Oral Zunveyl for the Treatment of Alzheimer's Disease

Alpha Cognition has received approval for Zunveyl (benzgalantamine) delayed-release oral tablet formulation for the treatment of mild-to-moderate Alzheimer’s disease in adults. Benzgalantamine is a prodrug of the active metabolite galantamine, an acetylcholinesterase inhibitor.

Genentech’s Vabysmo Prefilled Syringe (PFS) Approved for Retinal Eye Diseases

In July the FDA approved a 6 mg single-dose prefilled syringe (PFS) of Vabysmo (faricimab-svoa) for intravitreal (injection into the eye) to treat wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Vabysmo PFS delivers the same medicine found in the Vabysmo vials.

Zoryve Topical Cream OK’d for the Treatment of Atopic Dermatitis

This past month, the FDA cleared lower strength Zoryve (roflumilast) cream, 0.15%, indicated for the treatment of mild to moderate atopic dermatitis (AD) in adults and children 6 years of age and older. Zoryve is a once-daily, steroid-free cream used for long-term disease control.

FDA Clears Sun Pharma’s Leqselvi for the Treatment of Severe Alopecia Areata

Sun Pharma has announced approval of Leqselvi (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata.

FDA Approves Femlyv, the First Orally Disintegrating Birth Control Pill

Femlyv (ethinyl estradiol and norethindrone acetate) was approved in July as the first orally-disintegrating combination oral contraceptive (COC) for use by females of reproductive potential to prevent pregnancy. Femlyv is designed for individuals who have trouble swallowing their medication.

FDA Approves Erzofri to Treat Schizophrenia and Schizoaffective Disorder

Luye Pharma has announced approval of Erzofri (paliperidone palmitate) extended-release injectable suspension, an atypical antipsychotic used to treat schizophrenia and schizoaffective disorder in adults.

Epysqli is Now the Second Biosimilar to Soliris

In July the FDA approved Epysqli (eculizumab-aagh), a complement inhibitor biosimilar to Soliris (eculizumab) from Samsung Bioepis Co. Epysqli is indicated for the treatment of paroxysmal nocturnal hemoglobinuria in adults and atypical hemolytic uremic syndrome in adult and pediatric patients. Epysqli is not approved to treat hemolytic uremic syndrome due to Shiga toxin E. coli (STEC-HUS).

FDA Approves Once Daily Zituvimet XR for Adults with Type 2 Diabetes

The extended-release form of Zituvimet, known as Zituvimet XR (sitagliptin and metformin hydrochloride extended-release tablet) is now approved as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes. New extended-release strengths include 50 / 500, 50 / 1000 and 100 / 1000 sitagliptin / metformin tablets.

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