In the clinical research industry, every year brings forth remarkable advancements and breakthroughs. FDA plays a pivotal role in approving innovative treatments that offer hope and provide respite to patients battling various medical conditions. While FDA approved 55 new drugs and 34 therapies in 2023, let’s look at the FDA approvals in 2024.
From cutting-edge gene therapies to groundbreaking immunotherapies, these approvals mark significant milestones in the continuous pursuit of better health outcomes. In this short listicle today, let us explore the significant FDA approvals in 2024 so far. Each of the drug approvals represent a step forward in the fight against disease and improved quality of life.
1). Lenmeldy for Metachromatic Leukodystrophy (MLD)
Orchard Therapeutics’ Lenmeldy is among the key FDA approvals in 2024. The first FDA-approved gene therapy for MLD, it is offering hope to families of children affected by this rare genetic disease. Clinical trials demonstrate a significant reduction in the risk of severe motor impairment or death compared to untreated children.
2). Rezdiffra for Metabolic Dysfunction-Associated Steatohepatitis (MASH)
One of the crucial FDA approvals in 2024, Madrigal Pharmaceuticals’ Rezdiffra is the first treatment approved for MASH. The medical intervention showed promising results in resolving the condition without worsening fibrosis in patients with moderate to advanced liver scarring.
3). Breyanzi for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL)
Bristol Myers Squibb’s Breyanzi joined the list of FDA approvals in 2024 on March 14. The innovative drug gained FDA approval for CLL and SLL treatment, demonstrating notable complete response rates and overall response rates in clinical trials.
4). Tevimbra for Esophageal Squamous Cell Carcinoma
BeiGene’s Tevimbra has earned the FDA approval for unresectable or metastatic esophageal squamous cell carcinoma. The clinical studies showcased superior overall survival compared to chemotherapy.
5). Livmarli for Cholestatic Pruritus in Progressive Familial Intrahepatic Cholestasis (PFIC)
Mirum Pharmaceuticals’ Livmarli has secured the FDA approval for cholestatic pruritus treatment in PFIC patients, significantly improving symptoms and serum bile acid levels.
6). Wegovy for Cardiovascular Risk Reduction in Obesity
Novo Nordisk has gained one of the key FDA approvals in 2024 for its Wegovy. Approved for reducing cardiovascular risk in obese or overweight adults with cardiovascular disease, it demonstrated efficacy in reducing major adverse cardiovascular events.
7). Brukinsa for Follicular Lymphoma (FL)
BeiGene’s Brukinsa is also part of FDA approvals in 2024. It is the first BTK inhibitor approved for relapsed or refractory FL, showing superior overall response rates compared to standard treatments.
8). Opdivo Combo for Unresectable or Metastatic Bladder Cancer
Bristol Myers Squibb’s Opdivo, in combination with cisplatin and gemcitabine, received the FDA approval for unresectable or metastatic bladder cancer by demonstrating significant improvements in overall survival and progression-free survival.
- LetibotulinumtoxinA-wlbg for Frown Lines
Hugel America’s LetibotulinumtoxinA-wlbg is approved for treating frown lines between the eyebrows, showing significant treatment success in clinical trials.
- Exblifep for Urinary Tract Infection (UTI)
Allecra Therapeutics’ Exblifep gained FDA approval for complicated UTIs. One of the important FDA approvals in 2024, it demonstrated effectiveness against antimicrobial resistance in gram-negative bacteria.
- Simlandi for Various Conditions
Alvotech and Teva’s Simlandi is the first high-concentration, citrate-free and interchangeable biosimilar approved for various conditions including rheumatoid arthritis, psoriasis, and Crohn’s disease.
- Casgevy for Transfusion-Dependent Beta-Thalassemia (TDT)
Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy is also approved by the FDA as a one-time treatment for TDT. This approvals marks the first CRISPR-based gene-editing therapy for a solid tumor.
- Xolair for Food Allergies
Novartis and Roche’s Xolair received the FDA green signal for treating food allergies in children and adults. The drug displayed efficacy in desensitizing patients to peanut protein.
- Aurlumyn for Severe Frostbite
People affected by frostbite can rest easier now as Eicos Sciences’ Aurlumyn is approved as the first treatment for severe frostbite. It has showed considerable effectiveness in preventing amputation of frostbitten fingers or toes.
- Keytruda for Cervical Cancer
The FDA approvals in 2024 also include Merck’s Keytruda. To be administered in combination with chemoradiotherapy for cervical cancer treatment, the drug showed a reduction in disease progression or death compared to placebo.
- Zelsuvmi for Molluscum Contagiosum
Ligand Pharmaceuticals’ Zelsuvmi is approved as the first at-home treatment for molluscum contagiosum, showing effectiveness in reducing lesion counts.
- Tepmetko for Non-Small Cell Lung Cancer (NSCLC)
EMD Serono’s Tepmetko is granted full approval for NSCLC treatment in patients with MET exon 14 skipping alterations. It is based on significant overall response rates and duration of response.
- Aurlumyn for Molluscum Contagiosum
Ligand Pharmaceuticals’ Aurlumyn is approved for molluscum contagiosum treatment. The clinical trials displayed effectiveness and tolerability.
- Eohilia for Eosinophilic Esophagitis (EoE)
Takeda’s Eohilia is approved as the first oral treatment for EoE, showing significant histologic remission rates compared to placebo.
- GAMMAGARD LIQUID for Chronic Inflammatory Demyelinating Polyneuropathy (CDIP)
Takeda’s GAMMAGARD LIQUID gains FDA approval for CDIP treatment, demonstrating a significant improvement in functional disability.
These groundbreaking FDA approvals in 2024 marks a significant year in the advancement of medical treatments, bringing hope and improved outcomes for patients facing challenging diseases and conditions. 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.