Announcement • Jul 20
Shionogi & Co., Ltd. Application For Expanded Pediatric Indication For Cefiderocol Accepted By U.S. FDA Shionogi & Co., Ltd. announced that its Supplemental New Drug Application (sNDA) for cefiderocol (U.S. product name "Fetroja"), a treatment for Gram-negative bacterial infections, has been accepted by the U.S. Food and Drug Administration (FDA) for the addition of indications for pediatric patients, including hospital-acquired pneumonia/ventilator-associated pneumonia (HABP/VABP) and complicated urinary tract infections (cUTIs), including pyelonephritis, caused by specific Gram-negative bacteria. This application is being submitted by Shionogi Inc., based on the results of three clinical trials that evaluated the pharmacokinetics, safety, tolerability, and efficacy of cefiderocol in 154 pediatric patients ranging from children born at 26 weeks of gestation to those under 18 years of age, in cases of confirmed or suspected Gram-negative bacterial infections such as HABP/VABP and cUTIs including pyelonephritis. The FDA has set a target date for completion of review (PDUFA date) for this application as February 23, 2027. Cefiderocol is listed on the World Health Organization's (WHO) list of essential medicines and plays an important international role as a treatment option for drug-resistant Gram-negative bacterial infections. Since 2023, it has been included in the WHO's Pediatric Drug Optimization (PADO) priority list, which identifies medicines that require particular development and distribution due to challenges such as dosage setting, safety data, and age-appropriate formulations in children. Efforts to expand the pediatric indication for HABP/VABP are supported through Project BioShield by the Biomedical Advanced Research and Development Authority (BARDA) and receive federal funding under a contract (contract number: 75A50126C00004) between the U.S. Department of Health and Human Services, the Strategic Preparedness and Response Office, and BARDA. Cefiderocol is a drug that effectively penetrates the outer membrane of Gram-negative bacteria, including drug-resistant strains, to exert its antibacterial activity. In the United States, cefiderocol is marketed for the treatment of adult patients with complicated urinary tract infections (cUTIs), including pyelonephritis caused by certain Gram-negative bacteria, and hospital-acquired pneumonia/ventilator-associated pneumonia (HABP/VABP), and is also marketed in several countries and regions, including Japan, Europe, and Taiwan. Preparations are underway to improve access to this new antibacterial agent for patients in many low- and middle-income countries through a tripartite collaboration agreement with The Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI). Announcement • Jul 08
Shionogi & Co., Ltd. to Report Fiscal Year 2027 Results on May 10, 2027 Shionogi & Co., Ltd. announced that they will report fiscal year 2027 results at 3:30 PM, Tokyo Standard Time on May 10, 2027 Announcement • Jun 19
Shionogi & Co., Ltd. Achieves Primary Endpoint in Global Phase 3 Clinical Trial of Orolofim Shionogi & Co., Ltd. announced that it has achieved its primary endpoint in a global Phase 3 clinical trial (hereinafter referred to as the "OASIS trial" or "this trial") of ororofim, a novel antifungal drug being jointly developed with F2G Ltd. in patients with invasive aspergillosis. Orolofim is a novel oral antifungal drug with a novel mechanism of action that exhibits antifungal activity by inhibiting the pyrimidine synthesis pathway, which is essential for fungal growth. The OASIS trial, which yielded favorable results, was conducted to verify the non-inferiority of orolofim to the AmBisome treatment group (a group that received standard treatment after at least 10 days of AmBisome administration) in patients with invasive aspergillosis who were resistant to or for whom the use of azole antifungal drugs was difficult. In the primary endpoint, "all-cause mortality at 42 days after the start of treatment," orolofim demonstrated non-inferiority to the AmBisome treatment group (23.8% in the orolofim group, 24.3% in the AmBisome group, with a difference of -0.5% (95% confidence interval: -13.1% to 10.8%)). No new safety concerns were identified, and the incidence of adverse events that investigators determined to be drug-related was 35.8% in the orolofim group and 63.9% in the AmBisome treatment group. The orolofim group also showed a lower incidence of renal function-related adverse events, which are known side effects of the control drug. The results of the OASIS trial suggest that ororofim may be a new treatment option for invasive aspergillosis. Further details of the test results will be presented at international conferences and other venues in the future. Shionogi & Co., Ltd. is jointly developing Orolofim under an agreement with F2G, and holds the development and exclusive marketing rights in Europe and Asia. Based on the results of this trial, we plan to submit applications for approval in Europe and Asia, and F2G plans to submit a new drug application to the U.S. Food and Drug Administration (FDA). The impact of this matter on our consolidated financial results for the fiscal year ending March 2027 is expected to be minor. The Phase 3 clinical trial OASIS (Olorofim Aspergillus Infection Study, NCT05101187) is a global randomized controlled trial evaluating the efficacy and safety of orolofim and AmBisome compared to standard treatment in patients with invasive aspergillosis who are resistant to or have difficulty using azole antifungal agents. The primary endpoint of this trial is all-cause mortality at 42 days after the start of treatment, and secondary endpoints include clinical efficacy, safety, and quality of life (QOL). Ororofim is the lead compound of the orotomide-based antifungal drug class developed by F2G, and has completed a global Phase 3 clinical trial (OASIS trial). Ororofim has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for coccidioidomycosis, skedosporium disease, and invasive aspergillosis. It has also received Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive skedosporium disease, invasive lomentosporium disease, coccidioidomycosis, invasive infections caused by Scopulariopsis species, and invasive fusariosis. Furthermore, it has received orphan designation from the European Medicines Agency (EMA) for invasive aspergillosis, skedosporium disease, and invasive Scopulariopsis infections. Ororofim is currently an investigational compound and is not yet approved in any country or region. 
