New Drugs 2019

Intended Audience: Pharmacists

The number of new drugs approved each year has increased significantly since 1990. Various expedited approval pathways such as Orphan Drug Status designation, Accelerated Approval, Fast-Track, Priority Reviews, and the use of surrogate endpoints in studies have reduced the FDA review time from more than 3 years in 1983 to less than 1 year in 2017. In 2019, the FDA’s Center for Drug Evaluation and Research approved 48 novel drugs – a decline from 59 in 2018.

Novel drugs are often innovative products that serve previously unmet medical needs or significantly improve patient treatment. Twenty of the novel drugs approved in 2019 are first-in-class and others are significant therapeutic advances. This issue focuses on the new drugs or treatments that met these criteria in the therapeutic areas of acne, acute migraine, multiple sclerosis, plaque psoriasis, sleep disorders due to obstructive sleep apnea,and hypoactive sexual desire disorder in premenopausal women. Dosing and drug interactions are detailed in Table 1. Brief descriptions of selected, additional new drugs and combinations are shown in Table 2. Many biosimilars were FDA-approved in 2019; these are listed in Table 3. A brief explanation of biosimilars is also provided