Overview of Selected Novel Drugs Approved in 2018

Madison Donnelly & Shawn Hodge


2018 was a record setting year for new drug approvals by the FDA. This article highlights some of the drugs that have new mechanisms of action or have indications that have not previously been available. For example, Trogarzo is an IgG4 monoclonal antibody for the treatment of multidrug-resistant HIV. Xofluza, is a polymerase acidic endonuclease inhibitor that can be used to treat influenza by blocking a different step in the influenza lifecycle than previous flu medications, such as oseltamivir. Although smallpox has been declared eradicated for almost 40 years, TPOXX was approved for the treatment of smallpox in the event it is ever used as a bioterrorist agent. Epidiolex just became the first FDA-approved medication to contain an active ingredient derived from marijuana, and is the first medication approved for the treatment of Dravet syndrome. Three new medications for preventative migraine treatment were also approved. These agents (Aimovig, Ajovy, and Emgality) are calcitonin gene-related peptide receptor antagonists, which has been shown to be involved in migraine attacks.

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