2021 fda drug approvals with blockbuster potential

2021 FDA Drug Approvals
With BLOCKBUSTER
($1+ Billion) Potential
COVID-19 mRNA Vaccine: $36 Billion peak sales

Vygart, efgartimod : $3 Billion peak sales

Leqvio, inclisiran: $3 Billion peak sales

* Products that won Emergency Use Authorizations for deployment in
response to the pandemic such as the Moderna and Johnson & Johnson
vaccines are not included.

Source: FiercePharma

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2021 FDA Drug Approvals
Comirnaty

Active ingredient: COVID-19 Vaccine, mRNA
Disease: COVID-19
Peak sales estimate: $36 billion
Approved: Aug. 23
Company: Pfizer

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Source: FiercePharma

2021 FDA Drug Approvals
Vyvgart

Active ingredient: efgartigimod
Disease: myasthenia gravis
Peak sales estimate: $3 billion
Approved: Dec. 17
Company: argenx

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Source: FiercePharma


2021 FDA Drug Approvals
Tezpire

Active ingredient: Tezepelumab-ekko
Disease: severe asthma
Peak sales estimate: $2.5 billion in 2030
Approved: Dec. 17
Company: Amgen, AstraZeneca

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Source: FiercePharma


2021 FDA Drug Approvals
Cabenuva

Active ingredient: Cabotegravir and rilpivirine

Disease: HIV
Peak sales estimate: £2 billion (cabotegravir)
Approved: Jan. 21
Companies: GlaxoSmithKline’s ViiV Healthcare and
Johnson & Johnson’s Janssen

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Source: FiercePharma


2021 FDA Drug Approvals
Leqvio

Active ingredient: inclisiran
Use: lowering of low-density lipoprotein
cholesterol (LDL-C)
Peak sales estimate: More than $2 billion
Approved: Dec. 22
Company: Novartis

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Source: FiercePharma


2021 FDA Drug Approvals
Scemblix

Active ingredient: asciminib
Disease: chronic myeloid leukemia
Peak sales estimate: over $2 billion

Approved: Oct. 29
Company: Novartis

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Source: FiercePharma


2021 FDA Drug Approvals
Breyanzi

Active ingredient: Lisocabtagene maraleucel
Disease: Relapsed or refractory large B-cell
lymphoma
Peak sales estimate: $1 billion to $3 billion
Approved: Feb. 5
Company: Bristol Myers Squibb

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Source: FiercePharma


2021 FDA Drug Approvals
Verquvo

Active ingredient: Vericiguat
Disease: Chronic heart failure
Peak sales estimate: €1 billion
Approved: Jan. 19
Companies: Bayer and Merck & Co.

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Source: FiercePharma


2021 FDA Drug Approvals
Lupkynis

Active ingredient: Voclosporin
Disease: Lupus nephritis
Peak sales estimate: $1 billion by 2026
Approved: Jan. 22
Company: Aurinia

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Source: FiercePharma


2021 FDA Drug Approvals
Abecma

Active ingredient: idecabtagene vicleucel
Disease: Multiple myeloma
Peak sales estimate: $1.19 billion in 2026
Approved: March 26
Company: Bristol Myers Squibb

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Source: FiercePharma

2021 FDA Drug Approvals
Zynlonta

Active ingredient: Loncastuximab tesirine-lpyl
Disease: Certain types of relapsed or
refractory large B-cell lymphoma
Sales estimate: $1 billion by 2026
Approved: April 23
Company: ADC Therapeutics

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Source: FiercePharma


2021 FDA Drug Approvals
Lumakras

Active ingredient: Sotorasib
Disease: Lung cancer
Peak sales estimate: $1.3 billion by 2025
Approved: May 28
Company: Amgen

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Source: FiercePharma


2021 FDA Drug Approvals
Aduhelm

Active ingredient: aducanumab-avwa
Disease: Alzheimer’s
Peak sales estimate: $9 billion
Approved: June 7
Company: Biogen

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Source: FiercePharma


2021 FDA Drug Approvals
Kerendia

Active ingredient: finerenone
Disease: Chronic kidney disease associated
with Type 2 diabetes
Peak sales estimate: $1.1 billion by 2026
Approved: July 9
Company: Bayer

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Source: FiercePharma


2021 FDA Drug Approvals
Skytrofa

Active ingredient: lonapegsomatropin-tcgd
Disease: short stature due to inadequate
secretion of endogenous growth hormone

Peak sales estimate: $1.4 billion by 2026
Approved: Aug. 25
Company: Ascendis Pharma

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Source: FiercePharma


2021 FDA Drug Approvals
Tivdak

Active ingredient: tisotumab vedotin
Disease: cervical cancer
Peak sales estimate: $1.3 billion
Approved: Sept. 20
Companies: Seagen and Genmab

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Source: FiercePharma


2021 FDA Drug Approvals
Tavneos

Active ingredient: avacopan
Disease: vasculitis
Peak sales estimate: $1.3 billion by 2035
Approved: Oct. 8
Company: ChemoCentryx

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Source: FiercePharma


2021 FDA Drug Approvals
Voxzogo

Active ingredient: Vosoritide
Disease: Achondroplasia
Peak sales estimate: $1 billion
Approved: Nov. 19
Company: BioMarin

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Source: FiercePharma


2021 FDA Drug Approvals
Adbry

Active ingredient: tralokinumab
Disease: atopic dermatitis
Peak sales estimate: $1.6 billion in 2027
Approved: Dec. 28
Company: Leo Pharma

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Source: FiercePharma

Source: FiercePharma