Shots:     

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

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

• The major highlighted drug was Abbvie’s Emblaveo securing approval for treating Complicated Intra-Abdominal Infections (cIAI) 

1. AbbVie Reports the US FDA Approval for Emblaveo to Treat Complicated Intra-Abdominal Infections (cIAI) 

Company: Abbvie 

Product: Emblaveo 

Active Ingredient: Avibactam Sodium; Aztreonam 

Disease: Complicated Intra-Abdominal Infections (cIAI)   

Date: Feb 07, 2025   

Shots: 

• The US FDA has approved Emblaveo (IV) + metronidazole for pts (≥18 yrs) with few or no therapy options for cIAI caused by susceptible gram -ve bacteria, incl. E. coli, K. pneumoniae, K. oxytoca, ECC, C. freundii complex, & S. marcescens; commercially available in Q3’25 

• Approval was based on prior aztreonam’s efficacy & safety data for cIAI, plus P-III (REVISIT) trial, assessing Emblaveo ± metronidazole vs meropenem ± colistin in 422 pts with cIAI or nosocomial pneumonia (HAP/VAP); data published in The Lancet 

• Emblaveo combines aztreonam (monobactam) & avibactam (β-lactamase inhibitor) that protects aztreonam from serine β-lactamase (SBL) hydrolysis, while restoring its activity against MBL & SBL-producing bacteria 

2. SpringWorks Therapeutics Receives US FDA Approval for Gomekli to Treat Neurofibromatosis Type 1 Associated Symptomatic Plexiform Neurofibromas (NF1-PN) 

Company: Springworks Therapeutics

Product: Gomekli 

Active Ingredient: Mirdametinib 

Disease: Neurofibromatosis Type 1 Associated Symptomatic Plexiform Neurofibromas (NF1-PN)   

Date: Feb 11, 2025   

Shots: 

• The US FDA has approved Gomekli for pts (≥2 years) with unresectable NF1-PN based on P-IIb (ReNeu) trial & has also granted RPD PRV to SpringWorks; availability in US market is expected within 2wks; MAA is under EMA review with decision expected in 2025 

• The P-IIb (ReNeu) study assessed Gomekli (2mg/m^2, BID) in 2 Arms (N=114: 56 pediatric & 58 adults) & met its 1EP of ORR (52% & 41%) with durable tumor volume reduction of -42% (Range: -91 to 48%) & -41% (Range: -90 to 13%) 

• 90% children & 88% adults had response of at least ≥12mos., while 48% & 50% had responses for ≥24 mos. Both groups showed early, sustained pain relief & improved quality of life 

3. Ono Pharmaceutical Reports the US FDA Approval of Romvimza to Treat Symptomatic Tenosynovial Giant Cell Tumor (TGCT) in Adults 

Company: ONO Pharmaceutical 

Product: Romvimza 

Active Ingredient: Vimseltinib 

Disease: Symptomatic Tenosynovial Giant Cell Tumor (TGCT) 

Date: Feb 14, 2025   

Shots: 

• The US FDA has approved Romvimza to treat symptomatic TGCT in adults for which surgery may lead to functional impairment or severe morbidity. Commercially available in the US by Feb 2025, whereas MAA is under EMA review 

• Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without prior anti-CSF1/CSF1R therapy in 2 parts, where PBO pts could switch to Romvimza in part 2 after 24wks. 

• The P-III trial met its 1EP of improved ORR (40% vs 0%) in ITT pts, plus its 2EPs of ORR per TVS, improved active range of motion, patient-reported physical functioning, & pain observed at 25wks., with favorable safety as depicted by P-I/II data 

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