Sulopenem

Iterum Therapeutics (ITRM), Elevai Labs (ELAB), and Aclaris Therapeutics (ACRS) see significant search activity. Iterum's sulopenem, an anti-infective, received FDA approval for uUTIs. Elevai Labs focuses on skin aesthetics and obesity treatments, preparing for an FDA IND submission for EL-22 in 2025. Aclaris develops drug candidates for immuno-inflammatory diseases.

Iterum Therapeutics plc announced FDA approval of ORLYNVAH™, the first oral penem antibiotic for treating uncomplicated uUTIs in adult women caused by E. coli, K. pneumoniae, or P. mirabilis. The approval is based on Phase 3 trials showing ORLYNVAH™'s safety and efficacy, with common adverse reactions including diarrhea, nausea, and headache. Iterum's CEO emphasized the importance of this approval for patients with limited treatment options and plans to seek strategic transactions. uUTIs are prevalent, affecting up to 60% of women, with 1% caused by pathogens resistant to all commonly available oral antibiotics.

The FDA approved oral sulopenem (Orlynvah) for treating uncomplicated urinary tract infections caused by E. coli, K. pneumoniae, or P. mirabilis in adult women with limited treatment options. This is the first oral penem approved in the US, based on phase 3 trials showing its efficacy and safety compared to ciprofloxacin and amoxicillin/clavulanate. The approval aims to address rising antibiotic resistance and provide a safer alternative.

The FDA approved oral sulopenem (Orlynvah) for treating uncomplicated urinary tract infections caused by specific microorganisms in adult women with limited treatment options. This marks the first oral penem approved in the US, supported by phase 3 trials demonstrating its efficacy against fluoroquinolone-resistant infections and superiority over amoxicillin/clavulanate. The approval follows discussions on managing antimicrobial resistance risks.

Iterum Therapeutics announces FDA approval of ORLYNVAH™, the first oral penem for treating uncomplicated urinary tract infections (uUTIs) in adult women with limited treatment options. ORLYNVAH™, a combination of sulopenem etzadroxil and probenecid, demonstrated safety and efficacy in Phase 3 trials, offering a new treatment option in the underserved uUTI market.

Iterum Therapeutics announces FDA approval of ORLYNVAH™, the first oral penem for treating uncomplicated urinary tract infections (uUTIs) in adult women caused by specific microorganisms, offering a new option in the face of antimicrobial resistance.

The FDA faces decisions on Amgen's Lumakras for colorectal cancer, Camurus' subcutaneous octreotide for acromegaly, Iterum's oral sulopenem for uUTI, and Lexicon's Zynquista for type 1 diabetes and CKD, with target action dates in October.

A. Lenore Ackerman discusses the potential use of oral sulopenem for uncomplicated UTIs, emphasizing its role in high-risk patients with multi-drug-resistant infections, cautioning against its broad use due to concerns over resistance development.

FDA advisory committee raises concerns over antibiotic resistance and inappropriate use of sulopenem for uUTIs in adult women, emphasizing the need for appropriate use guidelines and potential modifications to drug labeling to mitigate risks.

Iterum Therapeutics discussed its NDA for oral sulopenem, a treatment for uUTI in adult women, with the FDA's AMDAC on Sept. 9, 2024. The committee reviewed the drug's benefits, risks, and appropriate use, with no voting held. Iterum awaits FDA approval by the PDUFA goal date of Oct. 25, 2024.