Neelam Sharma MS; Lavanya Kundurthy BE; and Hemant N. Joshi, PhD, MBA#- Tara Innovations LLC, # [email protected]; www.tara-marketing.com
This quarterly review of New Drug Applications contains data for applications approved during the first quarter of 2023, which includes New Molecular Entities (NMEs) and new biologics. A total of 29 applications were approved by the FDA during these three months.
Approvals during the first quarter of 2023 were divided into six different dosage forms: injection (41.4%), tablets (34.5%), capsules (3.5%), oral liquids - suspension/solution (10.3%), inhalation (3.5%) and metered dose inhalers (6.9%). The submission classifications were: BLA (3, 10.3%), Type 1 (new molecular entity, 9, 31.0%), Type 3 (new dosage form, 4, 13.8%), Type 4 (new combination, 4, 13.8%), and Type 5 (new formulation or manufacturer, 9, 31.0%).
Leqembi was approved via the accelerated approval pathway for the treatment of Alzheimer’s disease. Patients receiving this treatment had significant dose- and time-dependent reduction of amyloid beta plaque. The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designation.
The FDA approved Brenzavvy, which contained a new molecular entity – Bexagliflozin, a once-daily, oral sodium-glucose cotransporter 2 (SGLT 2) inhibitor for the treatment of adults with Type 2 diabetes. It lowers blood sugar by causing the kidneys to remove sugar from the body through urine. It shows modest decreases in both body weight and systolic blood pressure.
Jesduvroq (Daprodustat) is indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. One must start with the lowest dose of Jesduvroq (dose range 1 mg to 24 mg daily) and the dose should not be increased more frequently than once in every four weeks.
Lamzede (velmanase alfa) is the first enzyme replacement therapy for the treatment of the non-central nervous system manifestations of alpha-mannosidosis, a rare genetic condition characterized by the lack of alfa-mannosidase enzyme in the body. Patients receive Lamzede as a 10-mg injection once a week.
FDA granted accelerated approval to Retifanlimab-dlwr (Zynyz) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This application was granted Priority Review, Fast Track, and Orphan Drug Designation.
FILSPARI™ (Sparsentan) is used to reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease progressing quickly. Sparsentan is the first single molecule Dual Endothelin Angiotensin Receptor Antagonist (DEARA) and received accelerated Fast-Track Approval.
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