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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

Balversa

erdafitinib

To treat adult patients with locally advanced or metastatic bladder cancer

Evenity

romosozumab-aqqg

To treat osteoporosis in postmenopausal women at high risk of fracture

Mayzent

siponimod

To treat adults with relapsing forms of multiple sclerosis

Sunosi

solriamfetol

To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea

Zulresso

brexanolone

To treat postpartum depression (PPD) in adult women

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

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