5 Medicines in Line to Storm the Market This Year

With 2023 bringing 55 new drug approvals, the pharmaceutical sector is poised to continue its streak. And the launch of every new treatment offers a light of hope for countless patients around the world.

The highly awaited drugs for 2024 revolve around a few key disease areas that are yet to see leaps in progress, including oncology, neurodegeneration, rare diseases, and cardiovascular health. It’s interesting to note that each of these drugs has seen more conservative sales forecasting following increased regulatory hurdles and lapses in efficacy of drugs post approval. Here we unveil the most anticipated launches of the year.

Neurodegenerative Disease

Eli Lilly’s Donanemab is an experimental Alzheimer’s drug, anticipated to reach sales of over $2 billion by 2028, a more conservative forecast following a projected $6 billion one year prior. After a series of refilings following unsatisfactory clinical results, Lilly is awaiting an FDA decision on its revisited drug design.

If approved, Lilly’s Donanemab will stand alongside only a few other key drugs in the market. In 2023 clinical studies, Donanemab showed an encouraging 35% delay in cognitive decline, and a 39% lower risk of the disease advancing in patients. However, Donanemab has seen a higher rate of particular side effects in patients, potentially raising concerns regarding the drug’s safety. That being said, Donanemab is undoubtedly one of the most long-awaited drugs by Alzheimer’s patients and their families worldwide, and the decision would be a landmark approval for the company.

Cancer

Geron’s Imetelstat may be the first telomerase inhibitor to be approved in the United States. Committed to research in the anti-aging space, Geron has been looking for other disease areas where Imetelstat could make its mark. Among the company’s early advisors is Elizabeth Blackburn, the Nobel Prize-winning discoverer of the telomerase enzyme itself.

Now used for myelodysplastic syndromes (MDS), a group of blood cancers, recent clinical studies with Geron’s Imetelstat showed transfusion independence in as early as eight weeks and that certain patients wouldn’t need new blood cell transfusions for at least one year following the drug. Once approved, Geron seeks to expand into intermediate and high risk myelofibrosis, unlocking an estimated $737 million in sales by 2028 for the company, and potentially an entry into the anti-aging market.

Astrazeneca and Daiichi Sankyo’s novel antibody-drug conjugate Datopotamab Deruxtecan (Dato-Dxd) aims to improve progression-free survival in patients with non-small cell lung cancer and breast cancer, and is estimated to generate sales of over $1.8 billion by 2028. A hopeful sequel to its first-generation Enhertu, reaching sales of over $1.6 billion post-approval, Dato Dxd is expected to add great value to both firms’ oncology portfolios and set to be another notable launch for the year.

Cardiovascular Health

Merck’s Sotatercept, an investigational activin signaling inhibitor therapy, targets pulmonary arterial hypertension. For a rare disease characterized by the narrowing of blood vessels in the lungs and significant strain on the heart, Merck’s new drug is the key target of its $11.5 billion acquisition of Acceleron Pharma in 2021. Sotatercept is estimated to generate sales of over $2 billion by 2028, and in September of 2023 Merck filed for Priority Review with the FDA.

Another promising drug in the sector is BridgeBio Pharma’s Acoramadis, a TTR stabilizer poised to capture a significant share of the transthyretin amyloid cardiomyopathy (attr-cm) market, currently dominated by Pfizer’s incumbent Vyndaqel. Pending FDA approval, it’s expected to generate sales of over $1 billion by 2028.

A Summary:

Other notable developments, including mRNA-1345, Resmetirom, and Ensifentrine are awaiting FDA approval. Read more about the latest FDA approvals here.

Learn more about drug discovery, the approval process, and further information on the latest FDA policies here.

©️ Copyright 2024

Legal Disclaimer:

The information provided in this article has been collected from various academic publications, industry reports/analyses, regulatory guidelines, media coverage, and legal analyses. The information provided is for general information purposes only and should not be construed for medical, legal, financial, or professional advice. Readers are advised to seek independent professional guidance where relevant. While we strive to ensure the accuracy and timeliness of our coverage, we claim no liability, representations, or warranties of any kind about the completeness, suitability, accuracy, reliability or availability of this article and all pertaining data within this article. Neither the author nor the publication will assume liability for any loss or damage arising from the use of the information provided in the article. The information within this article may be outdated or inaccurate over time, and neither the author nor the publication are obligated to update or revise such information. We reserve the right to modify, remove, or substantially edit the article, including the disclaimer, at any time.