RECENT FDA APPROVALS

Drug Name Manufacturer

colchicine (Lodoco®)

Agepha efgartigimod alfa/ hyaluronidase (Vyvgart® Hytrulo) Argenyx ritlecitinib (Litfulo™)

Pfizer

Description

New Drugs

• 505(b)(2) NDA approval 06/16/2023; Priority Review

• Indicated to reduce the risk of MI, stroke, coronary revascularization, and CV death in adult patients with established atherosclerotic disease or with multiple risk factors for CV disease

• Alkaloid

• Oral tablet: 0.5 mg

• Recommended dosage is 0.5 mg orally once daily

• Product availability is expected in 2H 2023

• BLA approval 06/20/2023; Orphan Drug

• Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are AChR antibody positive

• Combination neonatal Fc receptor blocker and endoglycosidase

• Injection: 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase per 5.6 mL (180 mg/2,000 units/mL) in a single-dose vial

• Recommended dosage for adults is 1,008 mg/11,200 units (5.6 mL) administered SC by an HCP over 30 to 90 seconds once weekly for 4 weeks, with subsequent treatment cycles based on clinical evaluation

• Safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatment cycle has not been established

• Product is currently available

• NDA approval 06/23/2023; Breakthrough Therapy; Standard Review

• Indicated for the treatment of severe alopecia areata in adults and adolescents ≥ 12 years of age

• Kinase inhibitor

• Oral capsule: 50 mg

• Recommended minimum dosage is 50 mg orally once daily; evaluation is recommended for TB, viral hepatitis, ALC, and up-to-date immunizations prior to initiating treatment

• Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants

• Boxed warnings for serious infections, mortality, malignancy, MACE, and thrombosis