FDA’s novel drug approvals stayed high in 2020

Jan. 5, 2021

Despite the upheaval caused by the coronavirus, the FDA managed to keep the wheels of its drug approvals process churning in 2020. 

Last year, the agency green lit 53 new molecular entities (NMEs) — surpassing 2019’s mark of 48 but falling short of 2018’s record setting year of 59.

The NME’s that passed muster at the FDA’s Center for Drug Evaluation and Research (CDER) target a host of therapeutic areas. Cancer-related approvals occupy the biggest portion of the pie, with about 20 novel drugs approved for various oncological conditions. CDER also added two new drugs to the growing list of approved antibody drug conjugates (ADCs): GlaxoSmithKline’s Blenrep and Immunomedics’ Trodelvy. ADCs, a more targeted type of cancer therapy, are increasingly being seen as a high-growth area of oncology with numerous patient benefits.

Some of the other notable approvals include Gilead’s remdesivir, which, so far, is the only therapeutic fully approved to treat COVID-19.

CDER also OK’d a new treatment for spinal muscular atrophy by Roche called Evrysdia, which some analysts have projected to become a blockbuster. 

Read the full list of 2020 NME approvals.