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
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
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
