What a ride 2020 has been so far. In a year full of wildfires, viruses, and well… ‘The Tiger King’, it can be difficult to focus on the positives. It’s not all doom and gloom, however – one aspect of 2020 that is actually rather promising is the world of novel pharmaceuticals. Here, we have listed the top five anticipated drug launches that have us really excited…
Alzheimer’s disease is by far the most common form of dementia1. Although most people are quite familiar with the devastating symptoms of the disease, many will be surprised to learn that it is the single largest cause of death in the UK, surpassing even cancer and heart disease2.
Despite this, however, there are – to date – absolutely no treatments to prevent, cure or slow its progression. This current gap in the pharmacopeia is absolutely astonishing, considering that 1 in 3 people develop the disease at some point in their life3, costing the NHS billions of pounds every year4.
However, in 2020, this could all change. This month, aducanumab has been accepted by the US FDA for priority review5. Co-developed by Biogen and Eisai, aducanumab is a monoclonal antibody drug, which targets the beta amyloid plaques that are often described as the pathological hallmark of Alzheimer’s disease. This drug binds to these plaques, reducing aggregation, and therefore slowing disease progression6.
If approved, this will be the first ever disease-modifying drug for Alzheimer’s disease – undoubtedly a hugely significant milestone for modern medicine as a whole.
Peanut allergies – another unsolved problem in modern society. Although a cure for this still lies in the distant future, a new drug has been developed to produce some degree of desensitisation.
Palforzia is an oral medication that actually contains small amounts of peanut – the dose of which is gradually increased over time, slowly desensitising sufferers to the common allergen7. This does not cure the allergy however, but simply desensitises patients to accidental consumption of small quantities.
Regardless, this is the first ever treatment for peanut allergies (another significant milestone for modern medicine), and could help sufferers feel safer while eating out at restaurants and cafés.
Although being recently approved by the FDA in the United States, whether or not it will gain approval in Europe has been a somewhat controversial topic. A 2019 meta-analysis suggested that the treatment actually increases anaphylaxis, rather than prevents it, but the accuracy of this remains unclear8. Regardless of this, developers Aimmune are confident that this drug will make a significant impact around the globe.
Palforzia is currently under review by the European Medicines Agency, with a decision expected by the end of the year9.
Rimegepant, a CGRP antagonist, is an upcoming drug used for the treatment of migraines.
CGRP, or calcitonin-gene-related protein, is a neuropeptide involved in migraine-associated pain transmission10.
Many therapies have been developed over the years in attempts to decrease CGRP levels, and therefore alleviate the pain which it induces. For example, monoclonal antibodies targeted at CGRP are a highly promising class of drug, which have been shown to reduce migraine-associated pain by up to 100%11. However, as with many antibody drugs, the requirement for subcutaneous injection precludes their widespread use.
CGRP antagonists, however, are administered orally, and either bind to CGRP itself, or to its receptor to reduce pain transmission.
Although another CGRP antagonist was approved by the FDA in late 2019, rimegepant developers Biohaven believe their drug will have a more successful launch, with a projected $897 million profit by 202412.
4. Oral Semaglutide
One of the most exciting classes of anti-diabetic drugs are the GLP-1 agonists.
GLP-1, or glucagon-like peptide-1, is an incretin hormone released from the gut in response to glucose absorption. GLP-1 goes on to bind to the GLP-1 receptor, thus enhancing the glucose-mediated secretion of insulin – producing a more powerful reduction of blood sugar levels. GLP-1 agonists mimic GLP-1 by binding to its receptor and evoking the same response13.
Although GLP-1 agonists have been around for a while, their success was expected to be greater than it turned out to be. One of the main reasons for this is their administration method – subcutaneous injection, often daily. This lead to low patient compliance, and therefore, poor results14.
However, in late 2019, the US FDA approved an oral formulation of GLP-1 agonist, semaglutide. This formulation of the drug is bound to a carrier protein, ‘SNAC’ which allows for safe and effective oral use15. This is likely to have a significant impact on the use of GLP-1 agonists, and perhaps the treatment of diabetes as a whole. EMA approval is expected shortly16.
The final upcoming drug on our list is Ozanimod, developed by Bristol-Myers Squibb.
Ozanimod has recently been approved by the FDA for use in multiple sclerosis, and acts as an S1P receptor agonist17. This prevents immune cells (lymphocytes) from exiting the lymph nodes – decreasing the total concentration of lymphocytes in the blood. As the primary cause of multiple sclerosis is the migration of these cells into the central nervous system, this is a highly logical treatment for the disease18.
Although the S1P receptor agonist market is already relatively well-occupied, experts project Ozanimod to make a huge profit of $5 billion by 2024, due to its less severe side effects compared to its opponents19.
EMA approval is expected shortly20.
The indications for this drug don’t end with multiple sclerosis, however. Bristol-Myers Squibb also aims to campaign for its approval for other inflammatory diseases, such as inflammatory bowel disease and ulcerative colitis21 – perhaps a blockbuster drug in the making.
Assuming all of these drugs gain approval, this year will claim revolutionary pharmacological advancements for Alzheimer’s disease, peanut allergies, migraines, type 2 diabetes and multiple sclerosis, all of which have the potential to change their respective fields forever, let alone the lives of the patients taking them. That isn’t all either – other anticipated drug launches include new cholesterol-lowering agents, as well as a whole plethora of anti-cancer medicines, among many others.
Maybe 2020 is looking up after all!
Chas Alexander Smith
- Alzheimer’s Society. 2020. Types Of Dementia. [online] Available at: https://www.alzheimers.org.uk/about-dementia/types-dementia
- The Office for National Statistics, 2020. Leading Causes Of Death, UK. London: ONS, pp.1-8.
- The Guardian. 2015. One-Third Of British People Born In 2015 ‘Will Develop Dementia’. [online] Available at: https://www.theguardian.com/society/2015/sep/21/one-third-of-people-born-in-2015-will-develop-dementia
- Alzheimer’s Society. 2014. Dementia UK Report. [online] Available at: https://www.alzheimers.org.uk/about-us/policy-and-influencing/dementia-uk-report
- Philippidis, A., 2020. FDA Accepts Biogen’s BLA For Alzheimer’s Candidate Aducanumab. [online] GEN – Genetic Engineering and Biotechnology News. Available at: https://www.genengnews.com/news/fda-accepts-biogens-bla-for-alzheimers-candidate-aducanumab/
- Schneider, L., 2020. A resurrection of aducanumab for Alzheimer’s disease. The Lancet Neurology, 19(2), pp.111-112.
- Smith, A., 2020. Palforzia Becomes First Peanut Allergy Drug To Get US Approval. [online] PharmaTimes. Available at: http://www.pharmatimes.com/news/palforzia_becomes_first_peanut_allergy_drug_to_get_us_approval_1324274
- Chu, D., Wood, R., French, S., Fiocchi, A., Jordana, M., Waserman, S., Brożek, J. and Schünemann, H., 2019. Oral immunotherapy for peanut allergy (PACE): a systematic review and meta-analysis of efficacy and safety. The Lancet, 393(10187), pp.2222-2232.
- Snack Safely. 2020. Results Of Aimmune’S Pivotal Phase 3 European Trial Of PALFORZIA® Published In The Lancet Child & Adolescent Health. [online] Available at: https://snacksafely.com/2020/07/results-of-aimmunes-pivotal-phase-3-european-trial-of-palforzia-published-in-the-lancet-child-adolescent-health/
- Durham, P., 2006. Calcitonin Gene-Related Peptide (CGRP) and Migraine. Headache: The Journal of Head and Face Pain, 46(1), pp.S3-S8.
- Han, L., Liu, Y., Xiong, H. and Hong, P., 2019. CGRP monoclonal antibody for preventive treatment of chronic migraine: An update of meta-analysis. Brain and Behavior, 9(2), p.e01215.
- Yun-Mi, K., 2020. Migraine Drug Market Heats Up With Ubrelvy’S Arrival – Korea Biomedical Review. [online] Korea Biomedical Review. Available at: http://www.koreabiomed.com/news/articleView.html?idxno=7083
- Hinnen, D., 2017. Glucagon-Like Peptide 1 Receptor Agonists for Type 2 Diabetes. Diabetes Spectrum, 30(3), pp.202-210.
- Kostev, K., Ouwens, M., Grandy, S., Johnsson, K. and Qiao, Q., 2016. Adherence to GLP-1 receptor agonist therapy administered by once-daily or once-weekly injection in patients with type 2 diabetes in Germany. Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Volume 9, pp.201-205.
- Bucheit, J., Pamulapati, L., Carter, N., Malloy, K., Dixon, D. and Sisson, E., 2020. Oral Semaglutide: A Review of the First Oral Glucagon-Like Peptide 1 Receptor Agonist. Diabetes Technology & Therapeutics, 22(1), pp.10-18.
- European Medicines Agency, 2020. First Oral GLP-1 Treatment For Type 2 Diabetes.
- Taylor, P., 2020.BMS Gets FDA Nod For Ozanimod, But Launch Will Be Delayed –. [online] Pharmaphorum.com. Available at: https://pharmaphorum.com/news/bms-gets-fda-nod-for-ozanimod-but-launch-will-be-delayed/
- Jo, E., Sanna, M., Gonzalez-Cabrera, P., Thangada, S., Tigyi, G., Osborne, D., Hla, T., Parrill, A. and Rosen, H., 2005. S1P1-Selective In Vivo-Active Agonists from High- Throughput Screening: Off-the-Shelf Chemical Probes of Receptor Interactions, Signaling, and Fate.Chemistry & Biology, 12(6), pp.703-715.
- Lui, A., 2020.Ozanimod. [online] FiercePharma. Available at: https://www.fiercepharma.com/special-report/2-ozanimod
- European Medicines Agency. 2020.Zeposia – European Medicines Agency. [online] Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/zeposia#assessment-history-section
- Bristol-Myers Squibb, 2020. Bristol Myers Squibb Announces Positive Topline Results From Pivotal Phase 3 True North Trial Evaluating Zeposia (Ozanimod) In Patients With Moderate To Severe Ulcerative Colitis. [online] Available at: https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-announces-positive-topline-results-pivota