What constitutes FDA's First in Class designation for New Molecular Entities?

Question

What constitutes a First in Class designation for new molecular entities? I’ve seen this term on FDA documents, as well as in databases (Chembl for example), but I was curious if there are any set criteria for First in Class drugs? The easy definition, in my mind, would be a drug that hits a novel target given its indication. However, if you look at antifungal drugs, you see that drugs with the same target for the same general indication (anti-fungal) treat completely different fungal infections because of their pharmacokinetics.

Are there discrete criteria for the FDA’s first-in-class designation for New Molecular Entities?

pharmacology

Are there discrete criteria for the FDA's first-in-class designation for New Molecular Entities?

z1273 · Answer

"First-in-class drugs are ones that use a new and unique mechanism of action for treating a medical condition. These products are often referred to as innovative and cited as offering new treatment options for patients."
Lanthier, M. et al. (2013) "An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011." J.Health Aff. (Millwood) 32:1433-9;
Pharmaceutical Research and Manufacturers of America. 2015b. Innovative Oncology Medicines Have Led to Impressive Gains in Patient Survivorship. Retrieved August 26, 2015. <www.phrma.org/innovative-oncology-medicines-have-led-to-impressive-gains-in-survivorship>."
From: Lexchin, J. (2016) "How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study" Healthc. Policy 12:65-7.

What constitutes FDA's First in Class designation for New Molecular Entities?

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