Sulopenem

Sulopenem received FDA approval for treating uncomplicated urinary tract infections (uUTI), outperforming ciprofloxacin and amoxicillin/clavulanate in phase 3 trials. The antibiotic is safe and well-tolerated, offering an alternative for resistant uUTIs.

Long COVID lacks specific diagnostic tests; experts call for validated biomarkers and advanced tools. Orlynvah, an oral penem, received FDA approval for treating UTIs in adult women. Avian influenza H5N1 cases rise, emphasizing One Health approach. Hepatitis B guidelines promote universal screening and vaccination. Pemivibart shows promise in reducing COVID-19 risk, with a 76% RRR over 12 months.

Iterum Therapeutics' Orlynvah approved for uUTIs, based on SURE1 and REASSURE trials. Orlynvah showed superiority over ciprofloxacin in resistant infections but not in susceptible ones, due to cipro's prolonged effect on bacterial flora. Cipro's safety issues led to its demotion as a first-line agent. REASSURE trial confirmed Orlynvah's efficacy in susceptible populations and non-inferiority overall, crucial for empiric therapy in community settings. Iterum seeks a strategic partner for Orlynvah's launch, aiming to address unmet needs and antibiotic resistance.

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.

FDA approves oral sulopenem (Orlynvah) for UTIs, based on phase 3 trials SURE 1 and REASSURE. Sulopenem showed superiority over ciprofloxacin for resistant infections and better response than amoxicillin/clavulanate. Orlynvah aims to address antimicrobial resistance and offers a new treatment option for uUTIs.

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.