Like every year, innovation was the keyword for the clinical research companies in 2023. Despite grappling with financial and regulatory challenges, the industry has received FDA approvals to 55 new drugs in the last year.
Having obtained the most number of approvals since 2018, the clinical trial organizations are now confident that the next 3 months would bring crucial FDA news. In this short blog, let us look at the 5 most exciting FDA decisions expected in the first quarter of 2024.
Merck’s Sotatercept
Merck’s focus on cardiovascular research brings Sotatercept into the spotlight as a potential breakthrough in treating pulmonary arterial hypertension (PAH). Originally developed by Acceleron Pharma, the drug’s revival demonstrated promise in addressing this life-threatening condition, leading to Merck’s $11.5 billion acquisition of Acceleron in 2021. With positive Phase 3 results, Sotatercept presents itself as a prospective game-changer, aiming to carve a niche in PAH treatment and offset revenue losses anticipated post-Keytruda’s patent expiration in 2028.
Despite the optimism, Sotatercept enters a competitive PAH market, raising questions about its commercial potential. The FDA’s decision, expected by March 26, holds the key to whether Sotatercept will stand out among its peers, offering a fresh approach to pulmonary arterial hypertension and reinforcing Merck’s position in cardiovascular research.
Iovance Biotherapeutics’ Lifileucel
Iovance Biotherapeutics has navigated a prolonged journey in the development of a groundbreaking therapy for advanced melanoma, known as Lifileucel. Stemming from the National Cancer Institute’s early work on tumor-infiltrating lymphocyte (TIL) therapy in the late 1980s, Iovance’s Lifileucel represents the first industrialized TIL therapy.
By mid-February, the FDA is set to decide on its approval, marking a potential milestone in personalized cell therapy for aggressive cancers. The decision will not only validate decades of research and development but could also open new avenues in cancer treatment, demonstrating the efficacy of TIL therapy in shrinking advanced tumors.
Eli Lilly’s Donanemab
Indianapolis-based Eli Lilly has set its sights on reshaping Alzheimer’s treatment with Donanemab. The company’s breakthrough came in Phase 3 trials, showing that Donanemab could modestly slow the mental and physical decline associated with Alzheimer’s disease. If the FDA grants approval this quarter, Donanemab is poised to compete with Eisai and Biogen’s Leqembi.
While Lilly’s triumph with the diabetes and weight loss drug Tirzepatide has already made waves, Donanemab represents a significant leap forward as it could redefine Alzheimer’s treatment.
Madrigal Pharmaceuticals’ Resmetirom
Madrigal Pharmaceuticals emerges as a potential pioneer with its Resmetirom to address metabolic dysfunction-associated steatohepatitis (MASH), previously known as NASH. The positive Phase 3 study results in 2022 positioned Madrigal’s filing as the most comprehensive clinical data package in MASH to date. This has generated optimism about Resmetirom’s potential to become the first-ever treatment for a condition estimated to affect millions.
Awaiting FDA approval by March 14, Resmetirom is highly anticipated, not only for its potential commercial success but also for the impact it could have on patients dealing with MASH. Madrigal’s journey serves as a focal point in the broader exploration of therapeutic solutions for MASH, and the forthcoming FDA decision will shed light on whether Resmetirom becomes a trailblazer in addressing this challenging condition.
Regeneron Pharmaceuticals’ Odronextamab
Regeneron Pharmaceuticals is navigating the competitive terrain of cancer therapeutics with its bispecific antibody, Odronextamab. The company, known for its earlier success with cancer immunotherapy Libtayo, is targeting follicular and diffuse large B cell lymphoma. Anticipating FDA approval by the end of March, Odronextamab represents a part of Regeneron’s strategy to compete more effectively in the cancer drug space.
With the FDA having cleared multiple bispecific drugs for lymphoma, Regeneron aims to demonstrate the unique value of Odronextamab. The decision on its approval will be a pivotal moment, indicating whether Regeneron can carve a niche in cancer treatment and elevate its standing in oncology therapeutics.
In conclusion, these FDA decisions could shape the future of the clinical trials industry as these breakthroughs unfold, promising potential shifts in how we tackle diseases. Stay tuned to our blog to read more relevant news from the industry. Do reach out to us at hello@inductivequotient.com to learn how our capabilities can power your clinical trials.