Industry Scorecard: New Drug Approvals and Blockbusters

By Patricia Van Arnum - DCAT Editorial Director

May 6, 2020

Is the blockbuster model still in play or has the paradigm to more specialized drugs and smaller patient populations narrowed the blockbuster field? DCAT Value Chain Insights looks at which drugs, approved over the past several years, have risen to the blockbuster class.

Inside new drug approvals 

To evaluate which recent new drug approvals by the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) have reached blockbuster status (defined as drugs achieving sales of $1 billion or more), new molecular entities (NMEs) approved by FDA’s CDER from 2015–2018 and their corresponding sales revenues, based on 2019 sales, were reviewed. Between 2015 and 2018, a total of 172 NMEs (See Figure 1 were approved. This included 45 NMEs in 2015, 22 NMEs in 2016, 46 NMEs in 2017, and 59 in 2018, a recent record high.

The blockbuster class

Figure 1 FDA NME 2010 2019

Of the 172 NMEs approved between calendar years 2015 and 2018, 20 NMEs went on to achieve blockbuster status (defined as sales of $1 billion or more) (see Table I at the end of the article ) or approximately 12% of the NMEs approved. Of these 20 NMEs, 18 NMEs, or 90%, were from the large pharmaceutical companies (see Figure 2).

Among the large pharmaceuticals, Roche led with three blockbuster NMEs approved (NMEs approved between 2015 and 2018) with Ocrevus (ocrelizumab), a drug for treating relapsing and primary progressive forms of multiple sclerosis, with approximate 2019 sales of $3.8 billion; Tecentriq (atezolizumab), now approved for multiple cancer indications and initially approved to treat bladder cancer, with 2019 sales of $1.9 billion; and Hemlibra (emicizumab) for treating Hemophilia A with 2019 sales of approximately $1.4 billion.

Figure 2 Large Pharma Blockbuster NME

Five companies—AstraZeneca, Gilead Sciences, Johnson & Johnson (J&J), Novartis and Novo Nordisk—each had two NMEs approved between 2015 and 2018 that went on to become blockbusters (see Figure 2 and Table I at the end of the article). AstraZeneca had Imfinzi (durvalumab), a drug to bladder cancer with 2019 sales of $1.5 billion and Tagrisso (osimertinib), a drug for treating advanced non-small-cell lung cancer with 2019 sales of $3.2 billion. Gilead Sciences scored with two NME combination drugs for treating HIV: Biktarvy (bictegravir, embitcitabine, tenofovir alafenamide fumarate) with 2019 sales of $4.7 billion and Genvoya (cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate) with 2019 sales of $4.0 billion. J&J had two recent NME approvals that went on to achieve blockbuster status: Darzalex (daratumumab), a cancer drug for treating multiple myeloma, with 2019 sales of $3.0 billion and Tremfya (guselkumab) for treating moderate-to-severe plaque psoriasis with 2019 sales of $1.0 billion. Novartis scored with Cosentyx (secukinumab), now approved for treating moderate-to-severe plaque psoriasis, psoriatic arthritis, or ankylosing spondylitis, with 2019 sales of $3.6 billion and Entresto (sacubitril; valsartan), a drug for treating heart failure, with 2019 sales of $1.7 billion. Novo Nordisk had two NMEs approved for Type II diabetes achieve blockbuster status: Ozempic (semaglutide) with 2019 sales of $1.7 billion and Tresiba (insulin degludec) with 2019 sales of $1.3 billion.

Figure 3 NME Sales 500m 1bn

AbbVie, Biogen, Eli Lilly and Company, Merck & Co., and Pfizer each had one NME approved between 2015 and 2018 that went on to achieve blockbuster status based on 2019 sales (see Figure 2 and Table I at end of the article).

Blockbuster contenders

Figure 3 outlines companies with strong sales (between $500 million and $1 billion (not counting $1 billion) of NMEs approved between 2015 and 2018. Table II at the end of the article provides further drug information, including indications and year of approval. 

 

Table I: New Molecular Entities Approved by the FDA, 2015–2019, Achieving Blockbuster Status (Sales of $1 Billion or More) Based on 2019 Sales.
Company Proprietary name (active ingredient); application type 2019 Sales Indication Year of Initial FDA Approval
AbbVie Mavyret (glecaprevir and pibrentasvir); NDA $2.9 billion Chronic hepatitis C virus 2017
AstraZeneca Imfinzi (durvalumab); BLA $1.5 billion Locally advanced or metastatic urothelial carcinoma in the bladder or urinary tract, or non-small cell lung cancer 2017
AstraZeneca Tagrisso (osimertinib mesylate); NDA $3.2 billion Metastatic non-small cell lung cancer 2015
Biogen Spinraza (nusinersen sodium); NDA $2.1 billion Infantile-onset spinal muscular atrophy (SMA), later-onset SMA, presymptomatic SMA 2016
Eli Lilly and Company Taltz (ixekizumab); BLA $1.4 billion Moderate to severe plaque psoriasis, active psoriatic arthritis, or active ankylosing spondylitis 2016
Gilead Sciences Biktarvy (bictegravir, embitcitabine, tenofovir alafenamide fumarate); NDA $4.7 billion HIV-1 infection 2018
Gilead Sciences Genvoya (cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate); NDA $4.0 billion HIV-1 infection 2015
Johnson & Johnson Darzalex (daratumumab); BLA $3.0 billion Multiple myeloma 2015
Johnson & Johnson Tremfya (guselkumab); BLA $1.0 billion Moderate-to-severe plaque psoriasis 2017
Merck & Co. Bridion (sugammadex); NDA $1.1 billion To reverse effects of neuromuscular blocking drugs used during surgery 2015
Novartis Cosentyx (secukinumab); BLA $3.6 billion Moderate to severe plaque psoriasis, psoriatic arthritis, or ankylosing spondylitis 2015
Novartis Entresto (sacubitril; valsartan); NDA $1.7 billion Heart failure 2015
Novo Nordisk Ozempic (semaglutide); NDA DKK 11.237 billion ($1.7 billion) Type II diabetes 2017
Novo Nordisk Tresiba (insulin degludec); NDA DKK 9.259 billion ($1.3 billion) Diabetes 2015
Pfizer Ibrance (palbociclib); NDA $5.0 billion Advanced (metastatic) breast cancer 2015
Roche Hemlibra (emicizumab); BLA CHF 1.380 billion ($1.4 billion) Hemophilia A in patients who have developed antibodies called Factor VII inhibitors 2017
Roche Ocrevus (ocrelizumab); BLA CHF 3.708 billion ($3.8 billion) Relapsing and primary progressive forms of multiple sclerosis 2017
Roche Tecentriq (atezolizumab); BLA CHF 1.875 billion ($1.9 billion) Locally advanced or metastatic urothelial carcinoma in the bladder or urinary tract, non-small cell lung cancer, triple-negative breast cancer, or small cell lung cancer 2016
Vertex Pharmaceuticals Orkambi (ivacaftor; lumacaftor); NDA $1.3 billion Cystic fibrosis in patients with certain mutations 2015
Vertex Pharmaceuticals Symdeko (tezacaftor; ivacaftor); NDA $1.4 billion Cystic fibrosis in patients with certain mutations 2018

Drugs approved as new molecular entities (NMEs) either as new drug application (NDA) or original biologics license application (BLA) by the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).

Year of approval indicates year in which the drug was first approved as a new molecule entity by FDA’s CDER.

Indication is for initial indication when first approved as an NME and subsequent approved indications.

Sales revenues are rounded. Currency conversions used reported on May 1, 2020: 1 CHF = $1.0399; 1 DKK = $0.1470

Source: Company information and US Food and Drug Administration’s Center for Drug Evaluation and Research.

 

Table II: New Molecular Entities Approved by the US Food and Drug Administration’s Center for Drug Evaluation and Research, 2015–2019, With Sales Between $500 Million and $1 Billion, Based on 2019 Sales Revenues.
Company Proprietary name (active ingredient); application type 2019 Sales Indication Year of Initial FDA Approval
AbbVie Venclexta (venetoclax); NDA $792 million Chronic lymphocytic leukemia or small lymphocytic lymphoma 2016
Alexion Pharmaceuticals Strensiq (asfotase alfa); BLA $593 million Perinatal/infantile-and juvenile-onset hypophosphatasia (abnormal development of bone and teeth) 2015
Allergan Vraylar (cariprazine hydrochloride); NDA $858 million Bipolar depression and bipolar I disorder in adults 2015
Amgen Parsabiv (etelcalcetide); NDA $630 million Secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis 2017
AstraZeneca Fasenra (benralizumab); BLA $704 million Severe asthma in patients with an eosinophilic phenotype 2017
Eli Lilly and Company Olumiant (baricitinib); NDA $543 million Moderately to severely active rheumatoid arthritis 2018
Eli Lilly and Company Verzenio (abemaciclib); NDA $580 million Advanced or metastatic breast cancer 2017
GlaxoSmithKline Nucala (mepolizumab); BLA £768 million ($960 million) Severe asthma in patients with an eosinophilic phenotype 2015
Johnson & Johnson Uptravi (selexipag); NDA $819 million Pulmonary arterial hypertension 2015
Neurocrine Biosciences Ingrezza (valbenazine); NDA $753 million Tardive dyskinesia (involuntary movements) 2017
Otsuka Pharmaceutical Rexulti (brexpiprazole); NDA JPY 89,822 million ($840 million) Major depressive disorder 2015

Drugs approved as new molecular entities (NMEs) either as new drug application (NDA) or original biologics license application (BLA) by the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).

Year of approval indicates year in which the drug was first approved as a new molecule entity by FDA’s CDER.

Indication is for initial indication when first approved as an NME and subsequent approved indications.

Sales revenues are rounded. Currency conversions used reported on May 1, 2020: 1 GBP = $1.2498; 1 JPY = $0.00931

Source: Company information and US Food and Drug Administration’s Center for Drug Evaluation and Research.