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:
To treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults
To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
To treat adult patients with locally advanced or metastatic bladder cancer
To treat osteoporosis in postmenopausal women at high risk of fracture
To treat adults with relapsing forms of multiple sclerosis
To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
To treat postpartum depression (PPD) in adult women
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”
To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP)
For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients