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Key takeaways
Blockbuster drugs are defined as pharmaceutical products that generate annual sales of at least $1 billion and are typically used to treat chronic conditions, significantly improving patients’ quality of life.
Bimekizumab (Bimzelx), an innovative treatment for various inflammatory diseases, has shown superior outcomes in Phase 3 trials but has not yet received FDA approval.
Delandistrogene moxeparvovec (Elevidys) is a groundbreaking gene therapy for Duchenne muscular dystrophy that was approved by the FDA in June 2023, targeting the genetic cause of the disease.
Lecanemab, approved by the FDA in January 2023, is a novel treatment for Alzheimer’s disease that targets and reduces amyloid beta plaques in the brain, indicated for patients in the early, mild stages of the disease.
As pharmaceutical scientists innovate, blockbuster drugs in your pharmacy also evolve. Even if you’re familiar with the term, you may be curious about what exactly makes a medication a “blockbuster drug” and what the potential blockbuster drugs of 2023 could be.
What is a blockbuster drug?
Blockbuster drugs are defined as highly sought-after pharmaceutical products that generate annual sales of at least $1 billion for the company that manufactures them. These drugs are typically used to treat chronic medical conditions. They can greatly reduce the severity of symptoms and improve the quality of life of those affected. In addition to making a significant clinical difference in patients’ lives, they also generate substantial profits for pharmaceutical companies.
Blockbuster drugs often shape research and development in the pharmaceutical industry, paving the way for newer medications. As a pharmacist, you can stay up-to-date on upcoming U.S. Food and Drug Administration (FDA) approvals and the latest blockbuster drugs to ensure your patients get the best treatment possible.
Read on to learn more about potential blockbuster drugs of 2023.
Bimekizumab (Bimzelx)
Bimekizumab is a dual anti-IL-17A and anti-IL-17F monoclonal antibody used to treat various inflammatory diseases. Manufactured by UCB, this novel therapy is designed to selectively and directly inhibit IL-17A and IL-17F, two cytokines that drive inflammatory processes responsible for plaque psoriasis. Bimekizumab has shown superior outcomes in Phase 3 trials, with patients experiencing improved skin clearance compared to existing treatments. Compared to other options, bimekizumab may have an improved safety profile and a less frequent dosing schedule. It has not yet received FDA approval.
Capivasertib (AZD5363)
Capivasertib, also known as AZD5363, is an investigational oral therapy targeting the serine/threonine protein kinase AKT, a key enzyme in cell growth and survival. This potent, selective AKT inhibitor developed by AstraZeneca shows promise as a potential treatment for breast cancer. In one clinical study, capivasertib, in combination with fulvestrant, significantly improved progression-free survival in patients with aromatase inhibitor-resistant advanced breast cancer. The drug was granted priority review by the FDA in June 2023.
Delandistrogene moxeparvovec (Elevidys)
Delandistrogene moxeparvovec is a groundbreaking gene therapy used for treating Duchenne muscular dystrophy (DMD). Developed by Sarepta Therapeutics, this therapy has gained considerable attention as it targets the underlying genetic cause of DMD. It’s an adeno-associated virus vector that delivers a gene that produces micro-dystrophin, a modified version of the naturally occurring dystrophin protein in healthy muscle cells. This treatment was approved by the FDA in June 2023, for ambulatory pediatric patients aged 4 through 5 years with a confirmed mutation in the DMD gene.
Donanemab (N3pG)
Donanemab is a promising investigational monoclonal antibody therapy for Alzheimer’s disease. Developed by Eli Lilly, it targets a specific form of amyloid-beta that is found in aggregated amyloid plaques. What sets donanemab apart from similar antibodies is its ability to strongly bind to deposited amyloid plaques. In a recent trial conducted by Eli Lilly, donanemab demonstrated the ability to slow cognitive decline by 35% in some participants. This promising result led the FDA to grant it Breakthrough Therapy designation in June 2021, which could accelerate its development and approval.
Lebrikizumab (INN)
Lebrikizumab is a monoclonal antibody and immunosuppressive drug that was initially studied as an asthma treatment. Its use then pivoted to treating eczema, and the FDA granted Lebrikizumab Fast Track approval in December 2019. Developed by Eli Lilly, this promising drug recently hit its Phase 3 topline targets in atopic dermatitis (AD) trials. Lebrikizumab is an IL-13 inhibitor that may help reduce inflammation and symptoms associated with AD. Clinical trials have shown that lebrikizumab, when dosed every two or four weeks, improves skin clearance in patients with moderate-to-severe atopic eczema.
Lecanemab (Leqembi)
Lecanemab is a groundbreaking treatment for Alzheimer’s disease that was approved by the FDA in January 2023. The medication, manufactured by Eisai, targets and reduces amyloid beta plaques in the brain, which is a key factor in the progression of Alzheimer’s disease. It’s the first amyloid beta-directed antibody to receive traditional FDA approval. The medication is indicated for treating patients in the early, mild stages of the neurodegenerative disease, which may offer hope for those who may benefit from early intervention.
Teplizumab (Tzield)
Teplizumab is an anti-CD3 monoclonal antibody and the first FDA-approved treatment to delay the onset of stage 3 Type 1 diabetes in individuals with stage 2 Type 1 diabetes. Manufactured by Provention Bio and approved by the FDA in November 2022, teplizumab is intended for use in adults and pediatric patients aged 8 years and older. Teplizumab works by targeting the CD3 protein on T-cells, which prevents them from attacking pancreatic beta cells. As a result, teplizumab may help preserve or improve beta cell functions.
Tirzepatide (Mounjaro)
Tirzepatide is a drug developed by Eli Lilly that was FDA approved in May 2022 for the treatment of Type 2 diabetes. It’s currently in Phase 3 clinical trials for chronic weight management in individuals who are obese or overweight with at least one weight-related condition, such as high blood pressure or high cholesterol. Tirzepatide is unique in that it targets two major hormones that regulate blood sugar levels and help patients lose weight: GLP-1 and glucose-dependent insulinotropic polypeptide (GIP). In clinical trials, tirzepatide has demonstrated impressive results, with nearly half of overweight patients with diabetes losing at least 15% of their body weight.
Key takeaway
Blockbuster drugs, which are known to generate annual sales of $1 billion or more, are some of the most popular medications in the pharmaceutical industry. As we move toward the latter half of the year, keep an eye on new FDA approvals for 2023.
As approvals roll in, these medications may start to become more common on your pharmacy shelves. It helps to stay up-to-date on new drugs in the pipeline so you don’t get overwhelmed. You may also be in a better position to educate physicians and patients who may not yet be familiar with these new treatments, how they work, and their potential uses.