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Record Number Of FDA's New Drug Approvals


2018 marked a record year for new drug approvals, with 59 new molecular entities, or NMEs, getting the FDA's stamp of approval. The only other time the number of new drug approvals crossed 50 was in 1996 when the tally was 53.

Nineteen of the fifty nine novel drugs approved in 2018 are first in class, meaning these drugs often have mechanisms of action different from those of existing therapies. Some of the notable first-in-class novel approvals include Galafold for adults with Fabry disease, Trogarzo, a new type of antiretroviral medication for adult patients living with HIV-1 whose HIV-1 infection cannot be successfully treated with other available therapies, and Lucemyra, the first non-opioid drug product approved to help reduce opioid withdrawal symptoms.

Thirty four of fifty nine novel drugs in 2018 were indicated for the treatment of rare diseases, and some of which are Crysvita for X-linked hypophosphatemia, a rare, inherited form of rickets; Epidiolex for the treatment of two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome; and Palynziq to treat phenylketonuria (PKU), a genetic dietary condition in which patients are born with an inability to break down protein-containing foods and certain sweeteners, and which can lead to brain and nerve damage.

Another new drug that passed FDA muster in 2018 worth mentioning is Tpoxx, for the treatment of smallpox. Although the World Health Organization declared smallpox to be eradicated in 1980, there have always been concerns that this virus could be used as agents of bioterrorism.

Now let's take a look at the new drugs approved in December 2018.

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