FDA Approval Overview for January 2025

Omvoh (mirikizumab-mrkz)

On January 15, 2025, Eli Lilly announced that the FDA has approved Omvoh (mirikizumab-mrkz), a treatment for adult patients with moderate to severe active Crohn's Disease (CD). Following its approval in October 2023 as the first treatment for moderate to severe active ulcerative colitis (UC) in adults, Omvoh is now approved in the U.S. for the treatment of two types of inflammatory bowel disease (IBD). Mirikizumab-mrkz is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of the human IL-23 cytokine. By blocking its interaction with the IL-23 receptor, mirikizumab inhibits the release of pro-inflammatory cytokines and chemokines. This is the first biologic to offer two-year Phase 3 efficacy data for Crohn's Disease at the time of approval. The drug aims to reduce gastrointestinal inflammation, which is a key aspect of Crohn’s Disease pathology. Additionally, Eli Lilly has submitted Omvoh for approval in the European Union and Japan for Crohn's Disease and plans to submit it globally.

Lumakras (sotorasib)

On January 16, 2025, the FDA approved Amgen Inc.'s Lumakras (sotorasib) for use in combination with Vectibix (panitumumab) to treat adult patients with metastatic colorectal cancer (mCRC) who have a KRAS G12C mutation, as determined by FDA-approved testing. These patients had previously been treated with fluoropyrimidines, oxaliplatin, and irinotecan-based chemotherapy. The FDA also approved the QIAGEN therascreen KRAS RGQ PCR Kit as a companion diagnostic to identify colorectal cancer patients with the KRAS G12C mutation who may be eligible for Lumakras and Vectibix combination treatment.

Calquence (acalabrutinib)

On January 16, 2025, the FDA granted traditional approval for AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab to treat adult patients with previously untreated mantle cell lymphoma (MCL) who are not candidates for autologous hematopoietic stem cell transplantation (HSCT). The FDA also approved Calquence as a monotherapy for previously treated MCL patients. Calquence had received accelerated approval in 2017 for the same indication. This traditional approval signifies that the therapy met regulatory standards in the benefit-risk assessment.

Datroway (datopotamab deruxtecan or Dato-DXd)

On January 17, 2025, the FDA approved the antibody-drug conjugate Datroway (datopotamab deruxtecan or Dato-DXd), developed jointly by AstraZeneca and Daiichi Sankyo, for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, who have previously received endocrine therapy and chemotherapy for their disease. Datroway was globally approved in Japan in December 2024 for the treatment of HR-positive, HER2-negative, chemotherapy-treated, unresectable or recurrent breast cancer. Its application for approval in the European Union, China, and other regions is under review. The companies also announced plans to expand Datroway's label for the treatment of advanced EGFR-mutated non-small cell lung cancer. Datroway's application earlier this week received priority review, with a decision expected by July 12, 2025.

Spravato (esketamine)

On January 21, 2025, the FDA approved Johnson & Johnson's Spravato (esketamine) CIII nasal spray through a supplemental new drug application (sNDA), making it the first and only monotherapy approved for adults with major depressive disorder (MDD) who have not responded adequately to at least two oral antidepressants. MDD is one of the most common mental illnesses, with approximately 21 million adult patients in the U.S. Around one-third of these patients do not respond well to oral antidepressants, significantly affecting their quality of life. MDD presents a heavy economic burden, with nearly half of the costs attributed to treatment-resistant depression (TRD). This approval was based on positive results from a randomized, double-blind, multicenter, placebo-controlled study and received FDA priority review status.

Grafapex (treosulfan)

On January 22, 2025, Medexus Pharmaceuticals announced that the FDA has approved Grafapex (treosulfan) in combination with fludarabine for use as a preparatory regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients aged 1 year and older with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). Treosulfan is an alkylating agent used in conditioning treatment prior to an allogeneic bone marrow transplant to clear a patient's bone marrow and make space for transplanted cells to produce healthy blood cells.

On January 26, 2025, the FDA approved the supplemental biologics license application (sBLA) for Eisai Co., Ltd. and Biogen Inc.'s Leqembi (lecanemab-irmb) for maintenance dosing every four weeks for the treatment of patients with early Alzheimer's disease (AD), including mild cognitive impairment (MCI) or mild dementia (collectively early AD). This approval follows an 18-month initial treatment period with biweekly infusions, with the option to transition to a maintenance dose of 10 mg/kg every four weeks. The approval is based on modeling analyses of observational data from Phase 2 (Study 201), long-term extension studies, and the Clarity AD Phase 3 study (Study 301) and its LTE. Leqembi was initially approved through the accelerated approval pathway in January 2023 and was later converted to traditional approval following the confirmation of clinical benefit through a confirmatory trial, making it the first β-amyloid antibody for AD to be converted from accelerated to traditional approval.

Enhertu (fam-trastuzumab deruxtecan-nxki)

On January 27, 2025, the FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki), a HER2-targeted DXd antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo, for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultra-low (IHC 0, membrane staining) breast cancer who have previously been treated with at least one endocrine therapy. This approval is based on the results of the DESTINY-Breast06 Phase 3 trial.

Ozempic injection (semaglutide, 0.5 mg, 1 mg, or 2 mg)

On January 28, 2025, the FDA approved Novo Nordisk’s Ozempic injection (semaglutide, 0.5 mg, 1 mg, or 2 mg) for the reduction of the risk of kidney disease progression, kidney failure (end-stage kidney disease), and cardiovascular disease-related death in adult patients with type 2 diabetes and chronic kidney disease (CKD). This approval makes Ozempic the most broadly indicated GLP-1 receptor agonist (GLP-1 RA) in its class, with approved indications including improved blood sugar control in type 2 diabetes adults and reduced risk of major cardiovascular events in adults with type 2 diabetes and heart disease.

Symbravo (meloxicam and rizatriptan)

On January 30, 2025, the FDA approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute treatment of adult patients with or without aura migraine. SYMBRAVO uses an innovative multi-mechanistic approach to effectively target multiple pathophysiological pathways of migraine attacks, providing rapid pain relief and helping patients return to normal functioning, with effects lasting 24 to 48 hours after a single dose. The efficacy of SYMBRAVO was validated across various patient populations, including those with early mild migraine pain, moderate-to-severe migraine pain, and those with varied responses to previous acute treatments.

Journavx (suzetrigine)

On January 30, 2025, the FDA approved Vertex Pharmaceuticals' first-in-class non-opioid analgesic Journavx (suzetrigine) 50 mg oral tablets for the treatment of moderate to severe acute pain in adults. This drug works by targeting the pain signal pathway in the peripheral nervous system sodium ion channels, blocking the transmission of pain signals to the brain before they reach it, making it the first approved therapy in this mechanism of action class. This approval provides a new alternative to opioid medications.