Every year, the US FDA’s Center for Drug Evaluation and Research (CDER) releases a list of newly-approved novel drugs and therapeutic biological products. Last year’s Novel Drug Approvals list holds the record for the most number of approved drugs, effectively launching 59 promising treatments onto the market.
Since 2001, the CDER has averaged just under 23 NME approvals per year.
Of the 59 novel drugs and biologics approved in 2018, 34 (58%) were orphan drugs and 19 (32%) were first-in-class therapies.
Below is a running list of 2019’s Novel Drug Approvals and links to more information:
Vyndaqel
tafamidis meglumine
To treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults
Skyrizi
risankizumab-rzaa
To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
Sunosi
solriamfetol
To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
Egaten
triclabendazole
To treat fascioliasis, a parasitic infestation caused by two species of flatworms or trematodes that mainly the affect the liver, sometimes referred to as “liver flukes”
Cablivi
caplacizumab-yhdp
To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP)
Jeuveau
prabotulinumtoxinA-xvfs
For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients