FDA approved 50 new drugs in 2024, with major breakthroughs in oncology, neurology, and dermatology. Top approvals include BMS’ Cobenfy and Lilly’s Kisunla.
The pharmaceutical industry witnessed a year of steady progress in 2024, with the U.S. Food and Drug Administration (FDA) approving 50 new drugs. While this number was slightly lower than the 55 approvals in 2023, the quality of medical breakthroughs made up for the decline. Several highly anticipated treatments gained the green light, reshaping the landscape of therapy options across various disease areas.
Drug Approvals by Regulatory Agencies
- FDA CDER: Approved 50 new drugs, down from 55 in 2023.
- FDA CBER: Granted 14 biologics approvals, lower than 20 in 2023.
- European Medicines Agency (EMA): Approved 34 new therapies, up from 32 in 2023.
- Health Canada: Approved 28 drugs, down from 38 in 2023.
H2 2024: A Surge in FDA Approvals
In the first half of 2024, the FDA granted approvals for treatments in metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD). However, as the year progressed, approvals gained momentum. Of the 50 CDER approvals, 29 came in the second half of the year, accelerating the pace of drug authorizations.
Therapeutic Areas and Drug Types
- Oncology: Leading the pack, 15 of the 50 approvals (30%) targeted cancer treatments.
- Dermatology & Non-Malignant Hematology: Each accounted for 12% of approvals.
- Small Molecules: Dominated approvals, making up 64% of new drugs.
- Biologics: Represented 32% of approvals, including monoclonal and bi-specific antibodies.
Breakthrough Approvals: Cobenfy & Kisunla
Among the most awaited approvals were Cobenfy by Bristol Myers Squibb (BMS) and Kisunla by Eli Lilly.
- Cobenfy (xanomeline/trospium chloride): A first-in-class therapy for schizophrenia, offering a novel mechanism of action in psychiatric treatment. Analysts estimate peak sales to exceed $3.3 billion.
- Kisunla (donanemab): The third amyloid-targeting antibody approved for Alzheimer’s disease. Its limited-duration regimen sets it apart, reducing long-term costs. Priced at $32,000 per year, it is expected to reach $2.4 billion in peak sales.
Genetic & Rare Disease Therapies
- Crenessity (crinecerfont): The first treatment for classic congenital adrenal hyperplasia in decades.
- Alyftrek (deutivacaftor/tezacaftor/vanzacaftor): Vertex’s triple combination therapy for cystic fibrosis, forecasted to generate $8.3 billion in peak sales.
- Attruby (acoramidis hydrochloride): Bridgebio’s novel therapy for cardiac amyloidosis.
Cancer Drug Innovations
With oncology dominating approvals, several targeted therapies gained recognition:
- Itovebi (inavolisib): Genentech’s therapy for HR+, HER2-negative breast cancer, designed for patients with PIK3CA mutations. Roche projects peak annual sales of $2.3 billion.
- Unloxcyt (cosibelimab): Checkpoint Therapeutics’ PD-1/PD-L1-targeting monoclonal antibody for cutaneous squamous cell carcinoma.
- Vyloy (zolbetuximab): Astellas’ first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma, estimated to reach $850 million in peak sales.
- Revuforj (revumenib): Syndax Pharmaceuticals’ breakthrough menin inhibitor for acute leukemia.
Dermatology & Inflammatory Disease Approvals
- Ebglyss (lebrikizumab): Eli Lilly’s treatment for moderate-to-severe atopic dermatitis. With its monthly dosing regimen, it is poised to compete with Dupixent, potentially reaching $1.9 billion in sales by 2030.
- Nemluvio (nemolizumab): Galderma’s monoclonal antibody targeting IL-31, approved for prurigo nodularis and atopic dermatitis, forecasted to generate $1.66 billion in peak sales.
- Sofdra (sofpironium): Approved for primary axillary hyperhidrosis, a condition causing excessive sweating.
Endocrinology & Metabolic Disorders
- Yorvipath (palopegteriparatide): Ascendis Pharma’s hypoparathyroidism treatment, forecasted to hit $1.8 billion in sales by 2030.
FDA’s Improved Approval Process
One of the key trends in 2024 was asignificant reduction in complete response letters (CRLs). These declined from 43 in 2023 to 29 in 2024, reflecting better regulatory preparedness and industry compliance.
Looking Ahead to 2025
The first FDA approval of 2025 came in early January with Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, signaling another strong year ahead for oncology. Upcoming potential approvals include:
- Nipocalimab (J&J) – Targeting autoimmune diseases.
- Suzetrigine (Vertex Pharmaceuticals) – For neuropathic pain.
- Rivoceranib/camrelizumab (Elevar Therapeutics) – A new oncology therapy.
- Fitusiran (Sanofi) – A treatment for hemophilia.
- Gepotidacin (GSK) – A novel antibiotic.
Conclusion
2024 was marked by transformative drug approvals, especially in oncology, neurology, and rare diseases. With breakthrough therapies like Cobenfy and Kisunla, along with promising treatments in cancer and dermatology, the industry is set for another dynamic year ahead in 2025.
FDA
FDA
Comments are closed.
