Sales of the top 10 new drugs approved by the FDA are expected to peak at $16 billion in 2020

2020 is a special year for drug regulatory approval.
In part because the ongoing COVID-19 pandemic has delayed many clinical trials, but also because some highly anticipated drug applications have been unexpectedly rejected, such as Novartis' adult hyperlipidemia drug inclisiran, FibroGen's chronic kidney disease anemia roxadustat and Gilead's rheumatoid arthritis filgotinib.
the following 10 drugs are all new drugs that are expected to become heavy bombs when approved in 2020.
1, Evrysdi Pharmaceuticals: Roche Adaptation: Peak Sales of Spinal Muscular Dystrophy: $2.5-3 billion In August, the FDA approved Roche Evrysdi (risdiplam) for spinal myotrophy (SMA) in adults and children 2 months and older.
Evrysdi is a liquid preparation that can be delivered at home or by mouth or feeding tube once a day and can be used to treat infants, children, adolescents and adult patients of all types (type 1, type 2, type 3) SMA.
it's worth noting that Evrysdi was the first oral treatment for SMA and the first SMA treatment to be given at home.
Evrysdi is a motor neuron survival gene 2 (SMN2) mRNA shear modifier that treats SMA by increasing the production of motor neuron survival protein (SMN).
is found throughout the body and is essential for maintaining healthy motor neurons and exercise.
Pharma expects Evrysdi's sales to reach $803 million by 2024.
analysts predict that the Evrysdi could bring in $2.5 billion to $3 billion at its peak.
2, Trodelvy Pharmaceuticals: Immunomedics Adaptation: Peak Sales of Metastasis Triple Negative Breast Cancer: $2.3 billion In April 2020, Immunomedics announced that the FDA had accelerated approval of the listing of its antibody-coupled drug Trodelvy for the treatment of adult patients with metastasis triple-negative breast cancer (TNBC) who had received at least two treatments in the past.
Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug coupled that binds antibodies to TRAP-2 antigens expressed on most breast cancer cells and delivers chemotherapy drugs directly to the tumor cell microenviron.
note that Trodelvy is the first FDA-approved ADC drug specifically for relapsed or refractic mTNBC and the first FDA-approved anti-Trump-2 drug.
Trodelvy reduced the risk of disease progress or death by 59% compared to chemotherapy.
Pharma predicts Trodelvy's sales will reach $2.3 billion in 2026.
3, Nexletol Pharmacy: Esperion Adaptation: LDL-Cholesterol Sales Peak: $1.8 billion FDA approves Esperion's Nexletol (Biphenyl acid) in February 2020 to lower LDL-Cholesterol (LDL-C), an oral, daily, non-statin, LDL-C-lowering drug.
As an ad-side therapy for diet and maximum doses of statins, Nexletol can be used to treat adult patients with hexaling familial hypercholesterolemia (HeFH), as well as adult patients with atherosclerosis (ASCVD) that require further reductions in "bad" cholesterol (LDL-C) levels.
Nexletol's active pharmaceutical ingredient is bempedoic acid, a pioneering (first-in-class) ATP citric acid lysase (ACL) inhibitor that lowers LDL-C by lowering cholesterol biosynthetics and raising LDL subjects.
by Nexletol and supported by a key Phase III clinical program available 44.3
project included a number of Phase III clinical studies involving more than 3,000 patients.
these studies, Nexletol reduced LDL-C levels by 18 percent compared to placebos when combined with the maximum to-dosage statins.
Pharma expects Nexletol's annual sales to reach $1.8 billion by 2026.
4, Veklury (Remdesivir) Drugmaker: Gilead Adaptives: COVID-19 Sales Peak: $1,729 million Although the drug was urgently approved for COVID-19 treatment, a World Health Organization study found that Gilead Pharmaceuticals' antiviral drug Remdesivir had little effect on the mortality of COVID-19 patients.
, the price of the drug has been questioned.
Public Citizen, a U.S. consumer group, thinks the price is too high because the federal government has invested $70 million in the drug and sponsored a larger placebo trial.
with the launch of Pfizer BioNTech and Pfizer vaccines, Remdesivir is likely to be squeezed out of the market.
the drug remains Gilead's best-selling drug in the third quarter of 2020, bringing in $873 million in revenue.
Statista expects the drug to peak at $3,074 million in 2021, after which sales will fall to $1,729 million in 2026.
5, Zeposia Pharmaceuticals: Pershing Mesut Ozanimod Adaptation: Peak Sales of Multiple Sclerosis: $1.598 billion March 2020, Time Inc. announced that the U.S. FDA has approved Zeposia (Ozanimod) for the treatment of adult multiple sclerosis (RMS), including clinical isolation syndrome, relapsed remission disorders, and active progressive diseases.
Zeposia's active drug ingredient, ozanimod, is an oral S1P subjectulation regulator that selectively binds S1P1 and S1P5 with high affinity, and ozanimod selectively binds S1P1 is thought to inhibit the migration of activated lymphocytes from a specific subse group to inflammatory regions, reducing levels of circulating T lymphocytes and B lymphocytes that can lead to anti-inflammatory activity, thereby mitigating the immune system's neuromedular attacks.
estimated sales of the drug at $1.598 billion by 2024.
the drug was also one of the key reasons for the acquisition of Celgene by Shishi Shiguibao.
6, Bamlanivimab, REGN-COV2 Drugmakers: Lilly, Regenerative Meta-Adaptation: COVID-19 Sales Peak: $1.3 Billion November 2020, Lilly Announces Its New Coronavirus And Antibody Bamlanivimab (1) LY-CoV555) is approved by the FDA for Emergency Use (EUA) for the treatment of recently diagnosed new crown patients with mild to moderate risk in adults and children over 12 years of age, and Bamlanivimab needs to be injected intravenously as soon as possible within 10 days of diagnosis and symptoms, and cannot be used in hospital or in new crown patients requiring oxygen therapy.
, the FDA again urgently awarded the antibody cocktail casirivimab and imdevimab and REGEN-COV2 for the treatment of the corresponding patients with mild to moderate COVID-19.
, however, similar to Gilead Remdesivir, the long-term sales potential of the drug is unpredictable due to the vaccine's launch.
SVB Leerink expects the top sales of regenerative drugs to reach $1.3 billion in 2021 and decline year after year thereafter.
Bernstein analysts expect the total market for coVID antibodies to be about $3 billion by 2021, with Lilly and Regeneron split, but overall sales are expected to fall rapidly from current levels to about $805 million.
7, Tepezza Drugmaker: Horizon Adaptation: Peak Sales of Thyroid Eye Disease: $1.4 billion In January last year, the FDA approved Teprotumumab-trbw for the treatment of thyroid eye disease (TED).
TED is a serious, aggressive, vision-threatening, rare autoimmune disease associated with sudden eye (eyeball puffing), complex vision, blurred vision, pain, inflammation and facial defects.
Tepezza is an all-human monoclonal antibody and insulin-like growth factor-1-1R targeted preparation, injected every three weeks, a total of 8 injections.
Pharma predicts sales of the drug could reach $1.4 billion by 2026.
8, Palforzia Pharmaceuticals: Aimmune Allergy: Peak Food Allergy Sales: $1.28 billion Palforzia is the world's first approved treatment for peanut allergy and the world's first approved treatment for any food allergy.
, the FDA has granted fast-track and breakthrough drug eligibility for the drug to treat peanut allergies.
Palforzia is an oral immunotherapy (OIT) that is used in patients diagnosed with peanut allergies to reduce possible allergic reactions, including severe allergic reactions, after accidental ingestion of peanuts.
Palforzia can initiate treatment and maintenance therapy in children and adolescents between the ages of 4 and 17 and should continue to be taken at the age of 18 unless otherwise directed by the doctor.
, Nestle bought Aimmune for $2.6 billion, which has become a key pharmaceutical business for Nestle Health Sciences.
expected sales of the drug to reach $1.28 billion in 2024.
9, Kesimpta Pharmaceuticals: Novartis Adaptation: Relapsed Multiple Sclerosis Sales Peak: $1.26 billion as a subcutuplious injection drug, Kesimpta is approved to treat patients with multiple sclerosis (RMS) in adults with multiple hairstyles, including clinical isolation syndrome, relapsed/remissive diseases, and active secondary progressive diseases.
the drug is an all-humanized monoclonal antibody that targets CD20 and achieves the effect of removing B cells from the blood circulation by binding to CD20 on the surface of B cells.
Kesimpta is the first B-cell targeted therapy to allow patients to self-inject themselves at home once a month with Sensoready auto-injection pens, facilitating patient management of the disease.
, the drug's peak sales, is expected to be $1.26 billion.
10, Nurtec Pharmaceuticals: Biohaven Adaptives: Acute Migraine Sales Peak: $897 million Nurtec ODT is the first and only FDA-approved quick-acting oral disintegrate tablet (ODT) dosage form of calcitonin gene-related peptide (CGRP) inhibitor.
Nurtec ODT has a novel, rapidly dissolved oral tablet form that treats the root cause of migraines by blocking the role of CGRP subjects.
Nurtec ODT is not an opioid or narcotic, is not addictive, and is not classified as a controlled drug by the U.S. Drug Enforcement Administration.
in clinical studies, a single oral Nurtec ODT can quickly relieve pain and restore normal function within an hour, with continuous efficacy for many patients for up to 48 hours.
there are currently three CGRP drugs on the market for migraines, Amjin and Novartic's Aimovig, Teva's Ajovy and Lilly's Emgality, but all three are injections.
Evaluate Pharma expects sales of the drug to reach $897 million in 2024.