Shots:
- PharmaShots has compiled a list of US FDA-approved drugs in the month of July 2025
- The US FDA has approved a total of 6 new drugs, including 5 new molecular entities and 1 biologic, leading to the treatment of patients and advances in the pharmaceutical industry
- The major highlighted drug was Regeneron’s Lynozyfic, securing FDA approval for tR/R Multiple Myeloma
Company: Dizal
Product: Zegfrovy
Active Ingredient: Sunvozertinib
Disease: EGFRm NSCLC
Date: Jul 02, 2025
Shots:
- The US FDA has granted accelerated approval to Zegfrovy for locally advanced or metastatic NSCLC associated with EGFR exon 20 insertion mutations (exon20ins) in pts whose disease has progressed on or after Pt-based CT
- Approval was based on the multinational WU-KONG1 part B trial assessing Zegfrovy in above mentioned pts, which showed significant improvement in ORR & DoR. Results were presented at ASCO 2024 & published in The JCO
- Additionally, FDA has approved Thermo Fisher’s Oncomine Dx Express Test as a next-generation sequencing (NGS) CDx for Zegfrovy to identify NSCLC pts with EGFR exon20ins by delivering NGS results in ~24hrs. when it is combined with Ion Torrent Genexus Dx System
Company: Regeneron
Product: Lynozyfic
Active Ingredient: Linvoseltamab-gcpt
Disease: R/R Multiple Myeloma
Date: Jul 02, 2025
Shots:
- The US FDA has granted accelerated approval to Lynozyfic for the treatment of r/r MM pts, who have received ≥4L therapy, incl. a proteasome inhibitor, an immunomodulatory agent & an anti CD38 mAb based on P-I/II (LINKER-MM1) trial in >300 pts; a SC P-I trial portion & IV P-II dose expansion portion is ongoing
- In the trial, 80 pts showed a 70% ORR & 45% CR rate per IRC, with a median time to first response of 0.95mos.; mDOR was unreached, & estimated DoR at 9 & 12mos. was 89% & 72%, respectively, among responders with mFU of 13mos.
- Additionally, Lynozyfic is being studied in P-III (LINKER-MM3) trial as a monotx. & P-Ib (LINKER-MM2) trial to treat r/r MM in combination with other cancer treatments
Company: KalVista
Product: Ekterly
Active Ingredient: Sebetralstat
Disease: Hereditary Angioedema
Date: Jul 03, 2025
Shots:
- The US FDA has approved Ekterly (sebetralstat) to treat hereditary angioedema (HAE) pts (≥12yrs.), with US availability expected immediately
- Approval was based on P-III (KONFIDENT) study assessing Ekterly (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries & KONFIDENT-S OLE study
- KONFIDENT data was published in The NEJM, which showed faster symptom relief, reduced attack severity & resolution, while KONFIDENT-S showed early attack treatment with a median initiation time of 10min. & a 1.3hr median time to symptom relief for laryngeal, abdominal, & breakthrough attacks
Company: LEO Pharma
Product: Anzupgo
Active Ingredient: Delgocitinib
Disease: Chronic Hand Eczema
Date: Jul 23, 2025
Shots:
- The US FDA has approved Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had inadequate response or are unamenable to topical corticosteroids
- Approval was based on P-III (DELTA 1 & DELTA 2) trials assessing Anzupgo (BID) vs vehicle in 960 adults with mod. to sev. CHE, both of which met their 1EP, with ≥2-point improvement in IGA-CHE TS at Wk. 16 (20% vs 10% & 29% vs 7%)
- Both DELTA 1 & 2 trials met their 2EPs, with 49% pts in each achieving ≥4-point HESD pain score reduction vs 28% & 23% as well as 47% pts in each achieving ≥4-point itch score reduction vs 23% & 20% at Wk. 16
Company: PTC Therapeutics
Product: Sephience
Active Ingredient: Sepiapterin
Disease: Phenylketonuria
Date: Jul 28, 2025
Shots:
- The US FDA has approved Sephience (sepiapterin) for the treatment of phenylketonuria (PKU) in pts of all ages, with broad labeling for hyperphenylalaninemia in adults & pediatric pts (≥1mos.) with sepiapterin-responsive PKU; review is ongoing in Japan & Brazil
- Approval was based on APHENITY study results & long-term extension data showing durable effects and improved dietary flexibility
- Sephience is an oral synthetic sepiapterin with a dual mechanism that boosts phenylalanine hydroxylase (PAH) enzyme activity
Company: LENZ Therapeutics
Product: Vizz
Active Ingredient: Aceclidine
Disease: Presbyopia
Date: Jul 31, 2025
Shots:
- The US FDA has approved Vizz (1.44% aceclidine ophthalmic solution) for the treatment of presbyopia in adults; samples are expected in the US by Oct 2025, with full commercial launch by mid-Q4’25
- Approval was based on the 3 P-III trials: CLARITY 1 & 2 evaluating Vizz (QD) in 466 pts for 42 days as well as CLARITY 3 to assess long term safety of Vizz in 217 pts for 6mos.
- In both CLARITY 1 & 2, Vizz met all 1 & 2EPs, showing rapid near vision improvement within 30min., lasting up to 10hrs., with consistent & reproducible results across both trials
Related Post: Insights+: The US FDA New Drug Approvals in June 2025
