HORIZON LINES: A Quarterly Review of New Drug Applications – January-March 2021

By: Neelam Sharma – MS,  and Hemant N. Joshi – Ph.D., MBA – Tara Innovations LLC – [email protected], www.tara-marketing.com

This quarterly review on New Drug Applications (NDAs) contains data for applications approved for the first time during the first quarter of 2021, which includes New Molecular Entities (NMEs) and new biologics. A total of 26 applications were approved by the FDA during these three months. 

During the first quarter of 2021, approvals were divided into four different dosage forms. Following are the percentages of those dosage forms – 26.9% oral tablets, 11.5% oral capsules, 57.7% injectable, and 3.8% oral extended-release suspension. Injectable dosage forms include solutions, suspensions and powder for suspension. The NDAs can be divided into five submission classifications. Following are the percentages in various classes – 50% Type 1 (new molecular entity), 10.7% Type 3 (new dosage form), 10.7% Type 4 (new combination), 25% Type 5 (new formulation or new manufacturer) and 3.6% BLA (Biologics License Applications).

Homozygous familial hypercholesterolemia (HoFH) is an ultra-rare inherited condition that affects approximately 1,300 patients in the U.S. and is characterized by extremely high low-density lipoprotein cholesterol (LDL-C). Evkeeza is the first FDA-approved treatment that binds to and blocks the function of angiopoietin-like 3 (ANGPTL3) and reduces LDL-C levels in all forms of HoFH including those with little or no LDL receptor activity.

Soluble guanylate cyclase (sGC) stimulators are a novel class of medications that promote endothelial and myocardial function with no known risk of hyperkalemia or stroke. Verquvo is the first Soluble Guanylate Cyclase Stimulator approved to treat heart failure. It will reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure. 

Lupus nephritis is an inflammation of the kidneys caused by lupus. Lupus is a disease that occurs when your body's immune system attacks your own tissues and organs (autoimmune disease). Lupkynis by Aurinia Pharmaceuticals is the first therapy for lupus nephritis.

Severe hypoglycemia is one of the most feared complications of diabetes treatment. It is an acute, life-threatening condition resulting from a critical drop in blood glucose levels associated primarily with insulin therapy. Zegalogue is Type-1 new molecular entity approved for treatment of severe hypoglycemia in patients with diabetes age 6 or older.

Pepaxto® is the first anti-cancer peptide-drug conjugate approved in multiple myeloma. This has been granted under accelerated approval based upon the HORIZON trial. Pepaxto® (melphalan flufenamide) is a novel and innovative therapeutic option in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma.

Figure 1.New Drug Applications - Table
Figure 2.New Drug Applications - Table

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