Amoxicillin/Clavulanate Potassium

AbbVie and Pfizer's Emblaveo is a combination of aztreonam (left) and avibactam (right), a beta-lactamase inhibitor that can restore the ability of aztreonam to fight the types of bacteria that can become resistant to most antibiotics. Ten months after Pfizer scored approval in Europe for Emblaveo (aztreonam and avibactam) to treat complicated intra-abdominal infections (cIAIs), AbbVie has done the same in the U.S., winning an FDA nod for Emblaveo for the same type of infections. In a collaboration between two of the industry’s largest drugmakers, AbbVie and Pfizer jointly developed Emblaveo, with the Illinois company holding its rights in the U.S. and Canada while its partner controls rights for the rest of the world.The FDA approval covers Emblaveo to be used in combination with the antibiotic metronidazole for patients with cIAIs who have limited or no other options.Emblaveo can be used to treat Gram-negative infections including E. coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex and Serratia marcescens.These infections can be difficult to treat as the bacteria causing them can become resistant to common antibiotics. Antimicrobial resistance (AMR) is a serious public health risk, causing an estimated 1.14 million deaths globally in 2021 with the potential to cause 39 million deaths by 2050, according to a study published last year in The Lancet.“The continued evolution of antimicrobial resistance among Gram-negative bacteria has left some patients with little to no treatment options, resulting in extended hospital stays, additional morbidity and death,” James McKinnell, M.D., infectious disease specialist at the Torrance Memorial Medical Center in California, said in a release. According to the World Health Organization, AMR “puts many of the gains of modern medicine at risk,” making infections harder to treat and other medical procedures—such as surgery, caesarean sections and cancer chemotherapy—much riskier.Emblaveo is a combination of aztreonam, a monobactam antibiotic, and avibactam, a beta-lactamase inhibitor that can restore the ability of aztreonam to fight the types of bacteria than can become resistant to most antibiotics. Emblaveo received qualified infectious disease product and fast track designations from the FDA in 2019. Grants from the Biomedical Advanced Research and Development Authority and the EU’s Innovative Medicines Initiative helped fund it development.AbbVie expects Emblaveo to become available in the third quarter of this year. The company did not reveal its price.“As bacteria evolve, industry, government, and clinical experts must work together to ensure that the infectious disease community has the tools to advance public health,” Roopal Thakkar, M.D., AbbVie’s chief scientific officer, said in the release.

ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades –Company to Host Conference Call on Monday, October 28 th at 8:30 a.m. EDT– DUBLIN, Ireland and CHICAGO, IL, USA I October 25, 2024 I Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This is the first approved indication for ORLYNVAH™ and the first FDA-approved product for Iterum. “We are so pleased to have achieved this historic milestone and would like to thank all the patients, investigators, Iterum colleagues and Iterum consultants and vendors who participated in the development of ORLYNVAH™. ORLYNVAH™ offers new hope for patients suffering from difficult-to-treat uUTIs. The introduction of novel products, like ORLYNVAH™, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians,” said Corey Fishman, Iterum’s Chief Executive Officer. “As the first oral penem approved in the U.S., ORLYNVAH™ offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market. With FDA approval and a clear label, we will renew our efforts to achieve a strategic transaction involving ORLYNVAH™ with the goal of maximizing value for our stakeholders.” The FDA approval of ORLYNVAH™ was based on a clinical development program supported by a robust data package, including two pivotal, Phase 3 clinical trials (known as SURE 1 and REASSURE) that evaluated the safety and efficacy of ORLYNVAH™ compared to ciprofloxacin (SURE 1) and Augmentin™ (REASSURE) in the treatment of adult women with uUTI. SURE 1 showed superiority to ciprofloxacin in fluoroquinolone resistant infections, while REASSURE showed non-inferiority and statistical superiority to Augmentin™ in the Augmentin™ susceptible population. ORLYNVAH™ was generally well tolerated in both SURE 1 and REASSURE clinical trials. “The FDA approval of ORLYNVAH™ is tremendous news for those of us who have been hoping for a new option to treat appropriate at-risk patients suffering from UTIs,” said Marjorie Golden, MD, FIDSA, Site Chief, Infectious Disease, St. Raphael Campus Yale New Haven Hospital. “Based on the totality of clinical data generated, ORLYNVAH™ has the potential to be an important treatment alternative for use in the community.” Conference Call Iterum will host a conference call on Monday, October 28, 2024, at 8:30 a.m. Eastern Time. The dial-in information for the call is as follows: United States: 1 833 470 1428 / International: 1 404 975 4839 Access code: 936149 The conference call replay will be available in the Events & Presentations section of Iterum’s website following the call. About uUTIs UTIs are among the most common bacterial infections encountered in the community. uUTIs are infections of the bladder occurring mainly in women. Up to 60% of women will have a uUTI in their lifetime. Up to 40% of women with a history of uUTI will have a recurrence of their infection. There are approximately 40 million uUTI prescriptions generated annually in the United States, and we estimate approximately 1% of those infections are caused by pathogens that are resistant to all commonly available classes of oral antibiotics. Rising antibiotic resistance, an aging population with comorbidities and sub-optimal safety profiles of existing oral treatment options are making antibiotic selection more challenging for treating physicians. About ORLYNVAH™ ORLYNVAH™ is a novel oral penem antibiotic for the treatment of uUTI. ORLYNVAH™ possesses potent activity against species of Enterobacterales including those that encode extended spectrum beta-lactamase (ESBL) or AmpC-type beta-lactamases that confer resistance to third generation cephalosporins. INDICATION AND IMPORTANT SAFETY INFORMATION INDICATIONS & USAGE ORLYNVAH™ a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uUTI caused by the designated microorganisms Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. Limitations of Use ORLYNVAH™ is not indicated for the treatment of: Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORLYNVAH™ and other antibacterial drugs, ORLYNVAH™ should be used only to treat uUTI that are proven or strongly suspected to be caused by susceptible bacteria. Culture and susceptibility information should be utilized in selecting or modifying antibacterial therapy. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS WARNINGS AND PRECAUTIONS ADVERSE REACTIONS The most common adverse reactions (≥2%) in patients treated with ORLYNVAH™ were diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting. DRUG INTERACTIONS USE IN SPECIFIC POPULATIONS To report SUSPECTED ADVERSE REACTIONS, contact Iterum Therapeutics plc at 1-866-414-SULO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About Iterum Therapeutics plc Iterum Therapeutics plc is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is advancing the development of its first compound, sulopenem, a novel penem anti-infective compound, with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received approval of its NDA for ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options by the U.S. Food and Drug Administration and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit www.iterumtx.com . SOURCE: Iterum Therapeutics