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Top 5 FDA Approvals from Q1 2025
The first quarter of 2025 saw approvals in diabetes, depression, kidney disease, and pain, among others. Read more about high-impact approvals of Q1 now.
The pace of medical innovation has never been faster. In 2024, the US Food and Drug Administration (FDA) approved a wave of transformative therapies that redefined treatment across multiple disease states. Semaglutide’s expanded cardiovascular indication changed the role of weight loss medications, while donanemab set a new standard for Alzheimer’s treatment. The first approved therapy for noncirrhotic NASH provided long-awaited hope for patients, and novel COPD therapies introduced entirely new mechanisms of action. These approvals weren’t just milestones—they set the stage for what’s to come.
If Q1 2025 is any indication, that level of advancement is here to stay. In just the first few months of the year, the FDA has already approved several breakthrough treatments, reinforcing the rapid evolution of drug development. Whether addressing widespread chronic diseases or tackling previously untreatable conditions, these new approvals are poised to impact millions of patients.
As we move further into 2025, the pipeline remains abundant for many specialties, with more high-impact decisions expected in the coming quarters. With this in mind, the HCPLive Editorial Staff has compiled a list of 5 FDA approvals from Q1 2025 set to make a lasting impact on healthcare.
Top 5 FDA Approvals from Q1 2025
Vutrisiran (Amvuttra)
Developer: Alnylam Pharmaceuticals
Approval Date: March 20
Indication: ATTR-CM
On March 20, 2025, the FDA announced the approval of vutrisiran (Amvuttra) for the treatment of adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). The approval was based on data from the phase 3 HELIOS-B trial, which demonstrated that vutrisiran reduced cardiovascular mortality, hospitalizations, and urgent heart failure visits in patients with ATTR-CM.
In the trial, vutrisiran was associated with a 28% reduction in risk for all-cause mortality and recurrent cardiovascular events compared to placebo. Safety analysis showed similar adverse event rates between vutrisiran and placebo, with no new safety concerns identified. The FDA previously approved vutrisiran for polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in June 2022.
Suzetrigine (Journavx)
Developer: Vertex Pharmaceuticals
Approval Date: January 30
Indication: Acute pain
On January 30, 2025, the FDA announced the approval of suzetrigine (Journavx) 50 mg oral tablets as a first-in-class non-opioid analgesic for the treatment of moderate to severe acute pain in adults. The approval represents the first new class of pain medicine approved in more than 20 years.
Suzetrigine reduces pain by targeting sodium channels in the peripheral nervous system before pain signals reach the brain. The approval was based on a pair of randomized, double-blind, placebo- and active-controlled trials in patients undergoing abdominoplasty and bunionectomy, both demonstrating superior pain reduction compared to placebo.
Semaglutide (Ozempic)
Developer: Novo Nordisk
Approval Date: January 28
Indication: Type 2 diabetes and chronic kidney disease
On January 28, 2025, Novo Nordisk announced the FDA approved semaglutide (Ozempic) to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). This approval was based on results from the phase 3b FLOW trial, which enrolled 3533 adults and was stopped early after meeting pre-specified efficacy criteria.
In the pivotal trial, semaglutide demonstrated a 24% relative risk reduction in major kidney and cardiovascular events compared to placebo when added to standard care. This approval expands semaglutide’s indications, making it the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class. Less than a month later, on February 21, 2025, Novo Nordisk announced the FDA declared the shortage of semaglutide injection (Ozempic) and semaglutide injection 2.4 mg (Wegovy) over.
Iptacopan (Fabhalta)
Developer: Novartis
Approval Date: March 20
Indication: C3 glomerulopathy
On March 20, 2025, the FDA approved oral iptacopan (Fabhalta) for adults with C3 glomerulopathy (C3G) to reduce proteinuria, marking the first approved treatment for this rare kidney disease. The decision was based on findings from the phase 3 APPEAR-C3G trial, which demonstrated a 35.1% reduction in 24-hour urine protein-to-creatinine ratio at 6 months. Additional analysis indicated a favorable impact on kidney function, with more iptacopan-treated patients meeting a composite renal endpoint compared to those initially receiving placebo. Iptacopan had previously received FDA approval for primary immunoglobulin A nephropathy and paroxysmal nocturnal hemoglobinuria.
Esketamine (Spravato)
Developer: Johnson & Johnson
Approval Date: January 21
Indication: Treatment-resistant depression
On January 21, 2025, Johnson & Johnson announced the FDA approved esketamine (Spravato) as the first monotherapy for adults with treatment-resistant depression (TRD).
In a phase 4 randomized, placebo-controlled study, esketamine alone showed a rapid and superior improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) scores at 4 weeks compared to placebo. Additional data from the ESCAPE-TRD trial indicated esketamine increased the likelihood of remission by 54% at eight weeks compared to quetiapine. The safety profile was consistent with prior data, and the treatment remains available only through the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) program. The approval provides an alternative for adults with TRD who do not respond to at least 2 oral antidepressants.
Read about more FDA approvals from the first quarter of 2025 and earlier here.
