HORIZON LINES: A Quarterly Review of New Drug Applications – April-June 2021

By: Neelam Sharma, MS and Hemant N. Joshi, PhD, MBA

Tara Innovations LLC [email protected]www.tara-marketing.com

This quarterly review of New Drug Applications (NDAs) contains data for applications approved during the second quarter of 2021. A total of 36 applications were approved by FDA during these three months. Interestingly, only six NDAs (16.7%) were approved in the month of April and 12 and 18 NDAs in the months of May and June 2021, respectively. Out of all NDAs approved, 19.4% and 80.6% were for large and small molecules, respectively. There are different types of NDAs. In this quarter, eight NDAs presented new drug molecules. In general, we observe many NDAs for heart disease. This time, only two NDAs were approved for heart disease. Ten NDAs were approved for cancer treatment (27.7% of total). Four NDAs were anti-infectives. Oral and injectables were the most popular dosage forms (44.5% each). 

Supernus Pharma received an NDA for a new molecule, Viloxazine. This is the first novel non-stimulant medication to treat ADHD in children. Viloxazine was marketed for more than two decades as an antidepressant in Europe.

Relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) remains a therapeutic challenge. Loncastuximab tesirine is an antibody-drug conjugate against CD19, an antigen expressed in many B-cell malignancies. ADC Therapeutics received an approval for Zynlonta, which contains Loncastuximab-tesirine-lpyl as an active. 

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired, life-threatening disease of the blood characterized by destruction of red blood cells by the complement system, a part of the body's innate immune system. This destructive process occurs due to deficiency of the red blood cell surface protein DAF, which normally inhibits such immune reactions. Empaveli is the first treatment for this disease.

Rylaze was approved as a component of a chemotherapeutic regimen for the treatment of ALL and LBL. Asparaginase erwinia chrysanthemi (recombinant)-rywn is used in patients who can no longer take asparaginase made from E. coli. It is a recombinant form of asparaginase made from the bacterium Erwinia chrysanthemi. G12C is one of several KRAS mutations found in cancer cells. The KRAS G12C mutation occurs in 13% of non-small-cell lung cancers and in 1-3% of colorectal cancers. Sotorasib (Lumakras by Amgen) is a new molecule to treat patients with this issue. Hbt Lab also received an approval to treat the same disease by an old molecule – Paclitaxel.

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