By - 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 third quarter of 2021. A total of 25 applications were approved by the FDA during these three months. Nine NDAs were approved in July, nine in August, and seven were approved in September. Out of all NDAs approved, 28% and 72% were for large and small molecules, respectively. In this quarter, nine NDAs (36%) presented new drug molecules. For oral delivery, nine NDAs were tablets/capsules and only one NDA was a solution. A total of thirteen injections formulations were awarded NDAs. One nasal spray and two topical formulations obtained NDAs. In prior years, the indications could be easily categorized as for heart disease, cancer, metabolic diseases. Now, there is a focus on specific targets, such as, Atogepant targets blocking CGRP receptors – CGRP protein cause migraine attacks.
OPZELURA cream contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. It is approved for a short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients.
Epidermal growth factor receptor exon 20 insertion (EGFRex20ins) mutations represent approximately 4–12% of EGFR mutations. FDA granted an accelerated approval for Exkivity (mobocetinib succinate) based on overall response rate and duration of response.
KORSUVA (difelikefalin) is a first-in-class kappa opioid receptor (KOR) that targets the body’s peripheral nervous system. It is the first and only FDA approved therapy for pruritis associated with chronic kidney disease (CKD). It received a priority review, which is expected to offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
Twyneo cream contains 0.1% tretinoin and 3% benzoyl peroxide. It uses Sol-Gel’s patented technology to entrap tretinoin, a retinoid, and benzoyl peroxide within silica-based microcapsules to stabilize tretinoin from being degraded by benzoyl peroxide and to slowly release each of the active drug ingredients over time to provide a favorable efficacy and safety profile.
Pompe disease is a rare (estimated at 1 in every 40,000 births), inherited and often fatal disorder that disables the heart and skeletal muscles. It is caused by mutations in a gene that makes an enzyme called acid alpha-glucosidase (GAA). Nexviazyme received FDA approval under Fast Track, Priority Review and Breakthrough Therapy designations. Nexviazyme also received an orphan drug designation.
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