FDA's Center for Drug Evaluation and Research approved fewer new treatments in 2019.
While FDA’s overall new drug approvals dropped in 2019, small molecular drugs continue to lead the way in novel approvals.
“Smaller molecules are more likely to be designated as first in class or breakthrough therapies by the FDA, compared to [other molecules] that aren’t structurally novel,” Todd Wills, managing director at CAS, which collects and analyzes the world’s disclosed science, told FormularyWatch.
Compared to 59 new drug approvals in 2018, FDA approved 48 new drugs (not biologics), FDA’s Center for Drug Evaluation and Research said in a recent report.
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Small molecules are still the primary modality for new drugs, according to Wills, accounting for 70% of the drugs approved in 2019. Seventy-four percent of those drugs were structurally novel (based on new scaffolds).
The top 3 innovative small molecule approvals in 2019, according to Wills are:
1. Rozlytrek (entrectinib): “This is the third time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated,” Wills says.
2. Balversa (erdafitinib): This is first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer, Wills notes.
3. Mayzent (siponimod): the first oral drug specifically for patients with active secondary progressive multiple sclerosis (SPMS).
Center for Drug Evaluation and Research (CDER) noted FDA approved several innovative drugs in 2019, including:
Read more: Top 5 Drugs In The Pipeline