Trade Name: Cibinqo®
Company: Pfizer Inc.
Approval Dates/Comments: The US FDA granted a label extension for oral abrocitinib in February 2023, expanding the approved indications to include adolescents (12 to <18 years of age) with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Abrocitinib was previously approved only for the treatment of adults 18 years of age and older.
Lanadelumab-flyo SC injection
Trade Name: Takhzyro®
Approval Dates/Comments: In February 2023, the FDA approved the expanded use of lanadelumab-flyo, a human monoclonal antibody that targets plasma kallikrein, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients 2 to <12 years of age. Prior to this label extension, the only approved routine prophylaxis therapeutic options for children 6 to <12 years of age required dosing every 3 to 4 days, and children with HAE 2 to <6 years of age had no approved prophylaxis treatment, therefore this regulatory decision makes lanadelumab-flyo the first prophylaxis therapy for this age group.
Berdazimer gel, 10.3%
Trade Name: SB206
Company: Novan, Inc.
Approval Dates/Comments: A New Drug Application was submitted to the FDA in January 2023 seeking marketing approval for berdazimer gel, 10.3% for the topical treatment of molluscum contagiosum (MC). Berdazimer gel, 10.3% is in position to become a first-in-class topical treatment for MC. The active ingredient, berdazimer sodium, is a novel compound that releases nitric oxide and demonstrates antiviral activity. If approved, this drug would be the first effective and safe topical treatment indicated for MC with the convenience of self-application. Results from the pivotal Phase 3 B-SIMPLE4 clinical study evaluating berdazimer gel for the treatment of MC (NCT04535531) demonstrated a statistically significant improvement in the primary efficacy endpoint (p<0.0001), complete clearance of all lesions at week 12, and treatment was found to be well tolerated, with mild application site pain and mild to moderate erythema reported as the most common adverse events.
Methotrexate oral solution, 2 mg/mL
Trade Name: Jylamvo®
Approval Dates/Comments: In November 2022, the FDA approved this preparation of methotrexate (MTX) solution. The on-label indications are shared by the oral tablet formulations of MTX, which include severe, treatment‑refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment (e.g., phototherapy, psoralen and ultraviolet A radiation [PUVA] therapy, and retinoids), adults with severe psoriatic arthritis, and adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or part of a combination chemotherapy regimen.
Anticancer plasmid DNA vaccine
Trade Name: ITI-3000
Company: Immunomic Therapeutics
Approval Dates/Comments: The FDA granted Fast Track designation in November 2022 to the ITI-3000 program for the treatment of Merkel cell carcinoma (MCC). ITI-3000, a plasmid DNA (pDNA) vaccine, is being investigated in a Phase 1, open label, first-in-human study to evaluate the safety, tolerability, and immunogenicity of 4 mg of ITI-3000 in patients with Merkel polyomavirus-positive MCC.