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The US FDA New Drug Approvals in January 2025

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The US FDA New Drug Approvals in January 2025

Shots:     

  • PharmaShots has compiled a list of US FDA-approved drugs in the month of January 2025      

  • The US FDA has approved a total of 3 new drug including 2 new molecular entities and 1 biologic leading to the treatment of patients and advances in the healthcare industry       

  • The major highlighted drug was Daiichi Sankyo & AstraZeneca’s Datroway securing approval for treating unresectable or metastatic HR+/HER2- Breast Cancer 

 

 

1. Daiichi Sankyo and AstraZeneca Receives the US FDA Approval for Datroway (Datopotamab Deruxtecan-dlnk) to Treat HR+/HER2- Metastatic Breast Cancer 

Company: Daiichi Sankyo and AstraZeneca 

Product: Datroway 

Active Ingredient: Datopotamab Deruxtecan-dlnk 

Disease: Unresectable or Metastatic HR+/HER2- Breast Cancer 

Date: Jan 17, 2025   

Shots: 

  • The FDA has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in patients receiving endocrine-based therapy & CT. Submissions are under review in the EU, China, & other areas 

  • Approval was based on a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D) vs single agent CT (eribulin, capecitabine, vinorelbine or gemcitabine) in HR+/HER2- breast cancer patients (n=732) 

  • The trial showed improved PFS of 37%, mPFS (1EP; 6.9 vs 4.9mos.), ORR (2EPs; 36% vs 23%) with CR (2; 0.5% vs 0; 0%) & PR (131; 36% vs 84; 23%), plus mDoR (2EPs; 6.7 vs 5.7mos). Safety was favorable in 360 subjects & data was published in JCO 

 

2. Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine 

Company: Axsome Therapeutics 

Product: Symbravo 

Active Ingredient: Meloxicam and Rizatriptan 

Disease: Migraine 

Date: Jan 30, 2025   

Shots: 

  • The US FDA has approved Symbravo for acute treatment of migraine with/without aura in adults based on P-III (MOMENTUM), P-III (INTERCEPT) & P-III (MOVEMENT) trial; commercially available in ~4mons. 

  • MOMENTUM trial assessed Symbravo (single dose) vs PBO/meloxicam/rizatriptan, showing greater pain & symptoms freedom (photophobia, phonophobia & nausea) at 2hrs., sustained through 24-48hrs., 77% pts don't require rescue therapy within 24hrs. of dosing compared to rizatriptan from 2-24hrs. 

  • INTERCEPT trial also showed similar results, with 85% pts not requiring rescue therapy within 24hrs., while MOVEMENT trial showed its long-term safety in 706 pts, dosed intermittently for ~12mos. & treating ~2 migraines/mos. 

 

3. Vertex Receives the US FDA Approval for Journavx (Suzetrigine) to Treat Acute Pain 

Company: Vertex Pharmaceuticals 

Product: Journavx 

Active Ingredient: Suzetrigine 

Disease: Moderate-to-Severe Acute Pain   

Date: Jan 30, 2025   

Shots: 

  • The FDA has approved Journavx (50mg; BID) to treat moderate-to-severe acute pain in adults 

  • JOURNAVX is an oral, non-opioid pain signal inhibitor that selectively targets NaV1.8 relative to other NaV channels  

  • The company is also testing suzetrigine for peripheral neuropathic pain (PNP), with ongoing P-III trial for diabetic neuropathy and plans for lumbosacral radiculopathy studies, subject to regulatory discussions 

 

Related Post: Insights+: The US FDA New Drug Approvals in December 2024   


Dipanshu Dixit

A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com

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