Shots:
- PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2025
- The US FDA has approved a total of 5 new drugs, including 2 new molecular entities and 3 biologics, leading to the treatment of patients and advances in the pharmaceutical industry
- The major highlighted drug was Daiichi Sankyo and AstraZeneca’s Datroway, securing FDA approval for treating locally advanced or metastatic EGFR-mutated NSCLC previously treated with EGFR therapy & Pt CT
Company: George Medicines
Product: Widaplik
Active Ingredient: Amlodipine Besylate; Indapamide; Telmisartan
Disease: Hypertension
Date: Jun 05, 2025
Shots:
- George Medicines’ Widaplik (telmisartan, amlodipine, and indapamide) has been approved by the US FDA for treating adult hypertension, including as initial therapy; launch is anticipated in Q4’25
- The approval was supported by two P-III global studies showing Widaplik significantly improved blood pressure and control rates vs PBO & dual drug combinations
- Widaplik (GMRx2), a fixed-dose combo of telmisartan, amlodipine, and indapamide, is approved for treating hypertension, including initial therapy. It comes in three strengths: 10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg
Company: Merck
Product: Enflonsia
Active Ingredient: Clesrovimab-cfor
Disease: RSV Lower Respiratory Tract
Date: Jun 09, 2025
Shots:
- Merck’s Enflonsia has been approved by the US FDA to prevent RSV lower respiratory tract disease in newborns and infants entering their first RSV season, offering protection for up to 5mos. with a single 105mg dose, regardless of weight
- The approval was supported by the P-IIb/III (CLEVER) study of ENFLONSIA that demonstrated reduced RSV-associated lower respiratory infections by 60.5% (1EP) and hospitalizations by 84.3% (key 2EP) vs PBO. Additional P-III (SMART) study results supported its safety and efficacy, incl. in high-risk infants
- The US CDC committee will meet this month to recommend ENFLONSIA for infants; Ordering begins in July, with shipments expected before the 2025-2026 RSV season
Company: Nuvation Bio
Product: Ibtrozi
Active Ingredient: Taletrectinib Adipate
Disease: Locally Advanced or Metastatic ROS1+ NSCLC
Date: Jun 11, 2025
Shots:
- The US FDA has approved Ibtrozi (taletrectinib) for treating locally advanced or metastatic ROS1+ NSCLC
- Approval was based on the P-II [TRUST-I (China) & TRUST-II (global)] studies assessing Ibtrozi monotx. in 173 & 164 pts with ROS1+ NSCLC, respectively
- TRUST-I showed a cORR of 90% in TKI-naïve pts, with longest DoR of 46.9mos. & ongoing (mFU: 40mos.) while TRUST-II showed 85% cORR with DoR of 30.4mos. & ongoing, as of Oct 2024 (mFU: 19mos.); mDoR was not yet reached for either trial. Among TKI-pretreated pts, TRUST-I showed a cORR of 52% with a mDoR of 13.2mos. (mFU: 33mos.), & TRUST-II showed a cORR of 62% with a mDoR of 19.4mos. as of Oct 2024 (mFU: 19mos.); due to TRUST’s single-arm design, mPFS was not incl. in label
Company: CSL
Product: Andembry
Active Ingredient: Garadacimab-gxii
Disease: Hereditary Angioedema
Date: Jun 16, 2025
Shots:
- The US FDA has approved Andembry (garadacimab-gxii) for HAE pts (≥12yrs); commercially available before Jun 2025 end
- Approval was based on P-III (VANGUARD) trial assessing Andembry (n=39) vs PBO (n=25) for 6mos., which showed 62% pts remained attack-free, with reduction in overall HAE attacks by >99% median & 89.2% mean, as well as attacks requiring on-demand therapy by >99% median & 88% mean; >99% median & 90% mean reduction was also seen in mod./sev. attacks; data was published in The Lancet
- Interim analysis of the ongoing OLE study, with a median Andembry exposure of 13.8mos., demonstrated favorable long-term safety & sustained reductions in HAE attacks; data was published in Allergy
Company: Daiichi Sankyo and AstraZeneca
Product: Datroway
Active Ingredient: Datopotamab Deruxtecan-dlnk
Disease: Locally Advanced or Metastatic EGFR-Mutated NSCLC
Date: Jun 23, 2025
Shots:
- The US FDA has approved Datroway (datopotamab deruxtecan-dlnk; 6 mg/kg) for adults with locally advanced or metastatic EGFR-mutated NSCLC previously treated with EGFR therapy & Pt CT
- Approval was based on the global P-II (TROPION-Lung05) trial results (n=137) and supported by data from the P-III (TROPION-Lung01) trial (n=590), which showed a 45% confirmed ORR (n=114) with previously treated locally advanced or metastatic EGFR-mutated NSCLC, with 4.4% complete and 40% partial responses. mDoR was 6.5 mos.
- Daiichi Sankyo & AstraZeneca are testing Datroway alone or with osimertinib in advanced EGFR-mutated NSCLC in the P-III TROPION-Lung14 and Lung15 trials
Related Post: Insights+: The US FDA New Drug Approvals in May 2025
