RECENT FDA APPROVALS continued

Drug Name Manufacturer

atorvastatin calcium (Atorvaliq®) CMP velmanase alfa-tycv (Lamzede®) Chiesi pegcetacoplan (Syfovre™) Apellis

Description

New Drugs continued

• 505(b)(2) NDA approval 02/01/2023; Standard Review

• Indicated:

- To reduce the risk of (1) MI, stroke, revascularization procedures, and angina in adults with multiple risk factors for CHD but without clinically evident CHD; (2) MI and stroke in adults with T2DM with multiple risk factors for CHD but without clinically evident CHD; and (3) non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in adults with clinically evident CHD

- As an adjunct to diet to reduce LDL-C in (1) adults with primary hyperlipidemia and (2) patients ≥ 10 years old with heterozygous familial hypercholesterolemia (HeFH)

- As an adjunct to other LDL-C lowering therapies to reduce LDL-C in patients ≥ 10 years old with homozygous familial hypercholesterolemia (HoFH)

- As an adjunct to diet for the treatment of adults with (1) primary dysbetalipoproteinemia and (2) hypertriglyceridemia

• HMG-CoA reductase inhibitor

• Oral suspension: 20 mg/5 mL

• Recommended starting dosage in adults is 10 mg to 20 mg once daily; maximum dose is 80 mg once daily; recommended starting dose in pediatric patients is 10 mg to 20 mg once daily; maximum dose in pediatric patients with HoFH is 80 mg daily

• BLA approval 02/16/2023; Orphan Drug

• Indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients

• Recombinant human lysosomal alpha-mannosidase enzyme replacement therapy

• For injection: 10 mg lyophilized powder in an SDV for reconstitution

• Recommended dosage is 1 mg/kg, using actual body weight, administered IV once weekly by an HCP; pre-treatment with antihistamines, antipyretics, and/or corticosteroids should be considered

• Boxed warning for severe hypersensitivity reactions

• NDA approval 02/17/2023; Priority Review

• Indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

• Complement inhibitor

• For injection: 150 mg/mL solution in an SDV

• Recommended dosage is 15 mg (0.1 mL) administered via intravitreal injection by a qualified physician into each affected eye once every 25 to 60 days