Shionogi

Official Statements

Score contribution: 100 — 4 supporting sources.

Score 1004 references

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“In addition, through its Early Access Programs (EAPs) (also known as compassionate use, managed access, special access, expanded access, named patient, and temporary authorizations for use programs), Shionogi may be able to supply an investigational drug for a patient outside of a clinical trial and in accordance with the local regulatory process when each of the following conditions are met:”

SHIONOGI Group Managed Access Program PolicySource

“SHIONOGI Group (hereinafter called “SHIONOGI”) strives to make certain investigational, unapproved, or approved but not yet commercially available treatments, available to patients who meet eligibility requirements via its Managed Access Programs (MAPs).”

Ensitrelvir Early AccessSource

“Early access to our investigational COVID-19 oral antiviral, ensitrelvir (generic name: ensitrelvir fumaric acid, Code No.: S-217622) for the treatment of COVID-19 may be provided for qualified patients with SARS-CoV-2 infection when approved therapies or a clinical trial of ensitrelvir are not options.”

SHIONOGIグループ未承認薬の提供に関するポリシーSource

“SHIONOGIは、マネージドアクセスプログラムを介して、適格要件を満たす患者さんに、治験中、未承認または承認済みであるがまだ市販されていない特定の医薬品を提供するよう努めています。”

EAP Related Articles from Sponsor

Score contribution: 80 — 5 supporting sources.

Score 805 references

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Shionogi Presents Real-World Evidence Showing Strong Efficacy with Fetroja® (cefiderocol) Against Treatment Resistant Bacterial Infections at IDWeek 2022Opens in new window

In an analysis of early use experience, including compassionate use where patients had limited treatment options, 80% (74/92) of patients treated with Fetroja reported clinical cure for difficult-to-treat Gram-negative infections.

ESCMID Global 2024: Shionogi presents real-world data demonstrating efficacy of Fetcroja® / Fetroja® (cefiderocol) in critically ill patients with certain difficult-to-treat bacterial infectionsSource

The study included 261 critically ill adult patients with limited treatment options who received cefiderocol for less than 28 days as part of Shionogi’s Early Access Program in Spain.

Shionogi, GARDP and CHAI Announce Landmark License and Collaboration Agreements To Treat Bacterial Infections by Expanding Access to Cefiderocol in 135 CountriesSource

Shionogi & Co., Ltd. (Shionogi) and the Global Antibiotic Research and Development Partnership (GARDP) have today announced the execution of a license and technology transfer agreement and, with the Clinton Health Access Initiative (CHAI), a collaboration agreement that aim to significantly transform the landscape of access to antibiotics for countries around the world.

Committed to Scientific ExcellenceSource

Shionogi may be able to supply an investigational drug for qualified patients with a serious disease and when alternative therapy and a clinical trial are not options.

PoliciesSource

- [SHIONOGI Group Managed Access Program Policy](https://www.shionogi.com/global/en/company/policies/shionogi-group-managed-access-program-policy.html)

Past EAPs on ClinicalTrials.gov

Score contribution: 40 — 1 supporting sources.

Score 401 references

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Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial InfectionsOpens in new window

Conditions: Bacterial Infections

Expanded Access Intelligence

Official Statements

Past EAPs on ClinicalTrials.gov

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