On January 15, 2025, Eli Lilly and Company announced that the FDA has approved Omvoh (mirikizumab mrkz) for the treatment of moderate to severe active Crohn's disease (CD) in adults. After being approved as the first treatment for moderate to severe active ulcerative colitis (UC) in adults in October 2023, Omvoh has now been approved in the United States for the treatment of two inflammatory bowel diseases (IBD). Mirikizumab mrkz is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine. By blocking the interaction with IL-23 receptors, mirikizumab inhibits the release of pro-inflammatory cytokines and chemokines. This is the first biologic therapy to provide two-year, three-year efficacy data for Crohn's disease upon approval. This drug aims to reduce inflammation of the gastrointestinal tract, which is an important aspect of Crohn's disease pathology. In addition, Eli Lilly has submitted listing applications for Omvoh for Crohn's disease in the European Union and Japan, and has stated plans for more global submissions.

On January 16, 2025, the FDA approved Amgen Inc.'s Lumakras (sotorasib) in combination with Vectibix (panitumumab) for the treatment of adult patients with metastatic colorectal cancer (mCRC) identified by FDA approved testing for KRAS G12C mutation. These patients have previously received chemotherapy based on fluorouracil, oxaliplatin, and irinotecan. At the same time, the FDA has approved QIAGEN's Therascreen KRAS RGQ PCR kit as a companion diagnostic device for identifying colorectal cancer patients with KRAS G12C mutations in their tumors who may be eligible for combination therapy with Lumakras and Vectibix.

On January 16, 2024, the FDA traditionally approved AstraZeneca's development of Calquence (acalabrutinib) in combination with bendamustine and rituximab for the treatment of previously untreated adult patients with mantle cell lymphoma (MCL) who do not meet the criteria for autologous hematopoietic stem cell transplantation (HSCT). The FDA has also approved Calquence as a monotherapy for adult patients with previously treated MCL. Calquence was granted accelerated approval for the same indication in 2017. This traditional approval marks that the therapy has met regulatory standards in risk benefit assessment.

On January 17, 2025, Datoway (datopotamab deruxtecan or Dato DXd), an antibody coupling drug jointly developed by AstraZeneca and First Three Partners, was approved for marketing by the US FDA for the treatment of adult breast cancer patients with unresectable or metastatic, hormone receptor (HR) positive, and human epidermal growth factor receptor 2 (HER2) negative (IHC 0, IHC1+, or IHC2+/ISH -). These patients had previously received endocrine therapy and chemotherapy for unresectable or metastatic diseases. Datroway was approved for the first time in the world in Japan last December to treat adult patients with unresectable or recurrent breast cancer who are hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+or IHC 2+/ISH -) and have received chemotherapy. At present, the marketing application of Datroway for breast cancer treatment is under review in other countries and regions such as the EU and China. The two companies also stated that they are seeking to expand Datroway's label for the treatment of advanced EGFR mutant non-small cell lung cancer. Datroway's application received priority review earlier this week. A decision is expected to be made on July 12th.

On January 21, 2025, FDA approved the new drug supplement application (sNDA) for Spravato (esketamine) CIII nasal spray developed by Johnson&Johnson, making it the first and only single drug therapy for adult patients with severe depression (MDD) who have insufficient response to at least two oral antidepressants. MDD is one of the most common mental illnesses, with approximately 21 million adult patients in the United States, and about one-third of patients have poor response to oral antidepressants, severely affecting their quality of life. MDD has a heavy economic burden, with nearly half attributed to treatment resistant depression (TRD). This approval is based on the positive results of a randomized, double-blind, multicenter, placebo-controlled study and has been granted FDA Priority Review status.

On January 22, 2025, Medexus Pharmaceuticals announced that the FDA has approved the combination use of Grafapex (treatlfan) and fludarabine as a preparation for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients aged 1 year and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Treasulfan is an alkylating agent administered to patients prior to undergoing bone marrow transplantation known as allogeneic hematopoietic stem cell transplantation. It is used as a "conditioning" therapy to clear the patient's bone marrow and make room for transplanted bone marrow cells, which can then produce healthy blood cells.

On January 26, 2025, the FDA approved Eisai Co, The supplemental biologics license application (sBLA) for Leqembi (lecanemab irmb) administered intravenously every four weeks by Ltd. and Biogen Inc. LEQEMBI is suitable for the treatment of mild cognitive impairment (MCI) or mild dementia (collectively referred to as early-stage AD) in Alzheimer's disease (AD) patients within the United States. After completing the initial treatment every 2 weeks for 18 months, a transition to a maintenance dose regimen of 10 mg/kg every 4 weeks may be considered, or the treatment regimen of 10 mg/kg every 2 weeks may continue. This approval is based on modeling and analysis of observational data from the Phase 2 study (Study 201) and its Long Term Extended Study (LTE) of LEQEMBI, as well as the Clarity AD study (Study 301) and its LTE study. LEQEMBI was approved through the accelerated approval pathway in January 2023. Subsequently, based on a confirmatory trial, the clinical benefits of LEQEMBI were confirmed. The FDA announced the transition from accelerated approval to traditional approval, making LEQEMBI the first beta amyloid antibody drug for the treatment of Alzheimer's disease to transition from accelerated approval to traditional approval.

On January 27, 2025, the US Food and Drug Administration (FDA) has approved Enhertu (fam trastuzumab deruxtecan nxki), a specially designed HER2 directed DXd antibody drug conjugate (ADC), which is jointly developed by AstraZeneca and First Three Partners, to treat adult patients with unresectable or metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) - low (immunohistochemistry [IHC] 1+or IHC 2+/in situ hybridization [ISH]) or HER2- ultra-low (IHC 0, membrane staining) breast cancer. The FDA approved trial confirmed that the patient had metastasized in one or more endocrine treatments. Approval based on the results of DESTINY-Beast06 Phase III trial.

On January 28, 2025, FDA approved Novo Nordisk's Ozempic injection (semaglutide, 0.5 mg, 1 mg or 2 mg) to reduce the risk of kidney disease deterioration, renal failure (end-stage kidney disease) and cardiovascular disease death in adult patients with type 2 diabetes and chronic kidney disease (CKD). This approval makes Ozempic the glucagon like peptide-1 receptor agonist (GLP-1 RA) with the most extensive indications among similar drugs. Its approved indications also include improving blood glucose control in adult patients with type 2 diabetes and reducing the risk of major cardiovascular events in adult patients with type 2 diabetes who have heart disease.
On January 30, 2025, the FDA approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. SYMBRAVO adopts an innovative multi mechanism treatment method that effectively targets multiple pathological and physiological pathways of migraine attacks. It can quickly eliminate migraine pain and help patients recover normal function. The therapeutic effect can last for 24 to 48 hours after a single administration. The efficacy of SYMBRAVO has been validated in multiple types of patients, including those with mild early migraine pain, those with moderate to severe migraine pain, and those with varying responses to previous acute treatments.

On January 30, 2025, the FDA approved Vertex Pharmaceuticals' first non opioid analgesic drug Journavx (suzetrigine) 50 mg oral tablets for the treatment of moderate to severe acute pain in adults. This drug targets the pain signaling pathway of sodium ion channels in the peripheral nervous system, blocking the transmission of pain signals to the brain before they reach it, becoming the first approved therapy with such a mechanism of action. This application has obtained FDA breakthrough therapy, fast track, and priority review qualifications. This approval provides a new option for opioid drug alternatives.

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