Table 3. Special FDA Designations for 2020 Novel Drug Approvals.

Designation	Eligibility	Benefit	Drugs, No. (%) (N = 49)	Examples
Priority review	Drugs that may significantly improve safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions	Action taken on an NDA or BLA within 6 mo, rather than the standard 10 mo	28 (57)	Tazmetostat (Tazverik) Relugolix (Orgovyx)
Accelerated approval	Drugs that would treat serious conditions and fill an unmet medical need	Approval based on a surrogate or intermediate clinical end point, with required phase 4 confirmatory trials	12 (25)	Tafasitamab-cxix (Monjuvi) Nifurtimox (Lampit)
Fast track	Drugs that would treat serious conditions and fill an unmet medical need	Drug entitled to additional FDA meetings and input on trial design; rolling review; and eligibility for accelerated approval and priority review if certain criteria are met	16 (33)	Teprotumumab-trbw (Tepezza) Margetuximab (Margenza)
Breakthrough therapy	Drugs that would treat serious conditions and for which preliminary clinical evidence indicates improvement over available therapies on clinically significant end point(s)	Drug entitled to all aspects of fast track, intensive guidance on efficient drug development, and high-level organizational commitment from FDA	22 (45)	Artesunate (Artesunate) Ansuvimab-zykl (Ebanga)
Orphan drug	Drugs that treat diseases qualifying for orphan status, defined by 21 CFR Part 316 as those affecting fewer than 200 000 people in the US	Tax credits for qualified clinical testing and a waiver for the prescription drug user fee (unless the application includes a nonorphan indication)	30 (61)	Osilodrostat (Isturisa) Triheptanoin (Dojolvi)

Abbreviations: BLA, biologics license application; FDA, US Food and Drug Administration; NDA, new drug application.