Takeda - Expanded Access Programs

Expanded Access Intelligence

Official Statements

Score contribution: 100 — 1 supporting sources.

Score 1001 references

Featured Reference

“In einigen Fällen kann Takeda Patienten auch außerhalb einer klinischen Studie Zugang zu Prüfpräparaten gewähren: Im Rahmen eines sogenannten Härtefallprogramms (Compassionate Use Program). Ein solches Programm stellt in Deutschland eine Möglichkeit dar, unter bestimmten und streng regulierten Bedingungen Medikamente vor einer Zulassung zur Verfügung zu stellen. Wichtig ist hier, dass es sich um eine für den Patienten lebensbedrohliche und schwere Erkrankung handelt, die mit zugelassenen Optionen nicht zufriedenstellend behandelt werden kann. Für derartige Programme wird vorab vom Unternehmen ein Antrag zur Genehmigung bei der lokalen Behörde gestellt. Im Rahmen eines Härtefallprogrammes wird das entsprechende neue Medikament kostenfrei zur Verfügung gestellt.”

EAP Related Articles from Sponsor

Score contribution: 80 — 4 supporting sources.

Score 804 references

Featured Reference

Takeda Announces Favorable Phase 3 Safety and Efficacy Results of TAK-755 as Compared to Standard of Care in Congenital Thrombotic Thrombocytopenic Purpura (cTTP)Opens in new window

In addition to announcing these results, Takeda indicated that the December 22, 2022, edition of the New England Journal of Medicine (NEJM) included two case reports written and submitted by two physicians who requested compassionate use of TAK-755 to treat patients who were facing critical health complications related to cTTP.

Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung CancerSource

Takeda has established an Expanded Access Program (EAP) (NCT04535557) for patients in the U.S. who may be eligible to receive access to mobocertinib during the review of the NDA. Additional information about Takeda’s EAP is available here.

Racing Against Time, Medical Researchers, Life Science Companies and COVID-19 Survivors Launch National Campaign to Drive Blood Plasma DonationSource

The coalition partners are working on two distinct approaches for treating COVID-19 that both urgently require collection of convalescent plasma now. One approach is the direct transfusion of blood plasma though the Expanded Access Program for convalescent plasma, which is currently being administered with authorization from the Food & Drug Administration by Mayo Clinic.

米国FDAによるEGFRエクソン20挿入変異を伴う転移性非小細胞肺がんに対する治療薬mobocertinib（TAK-788）の新薬承認申請の優先審査指定についてSource

当社は、新薬承認申請審査中、mobocertinibの処方が適切と判断された米国の患者さんを対象として、拡大アクセスプログラム（Expanded Access Program: EAP）（NCT04535557）を実施しています。

Active EAPs on ClinicalTrials.gov

Score contribution: 60 — 5 supporting sources.

Score 605 references

Featured Reference

Expanded Access to Vedolizumab for Children and Teenagers With Ulcerative Colitis or Crohn's Disease in the USAOpens in new window

Conditions: Crohn's Disease, Ulcerative Colitis

Expanded Access to TAK-113 for Adults With Metastatic Colorectal Cancer (mCRC)Source

Conditions: Colorectal Cancer

Post Trial Access Program of TAK-577 for Von Willebrand Disease (VWD)Source

Conditions: Von Willebrand Disease (VWD)

Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter SyndromeSource

Conditions: Hunter Syndrome

Expanded Access to TAK-881 for Children and Teenagers With Primary Immunodeficiency Diseases in the USASource

Conditions: Primary Immunodeficiency Diseases (PIDD)

Past EAPs on ClinicalTrials.gov

Score contribution: 40 — 2 supporting sources.

Score 402 references

Featured Reference

Expanded Access Program With Pevonedistat (Given With Azacitidine) for Adults With Higher-risk Myelodysplastic SyndromesOpens in new window

Conditions: Myelodysplastic Syndromes

Expanded Access Program of TAK-755 for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)Source

Conditions: Thrombotic Thrombocytopenic Purpura (TTP)

Partner with Right2Hope

Right2Hope helps sponsors translate regulatory programs into actionable patient access pathways. Connect with our team to publish new programs, streamline intake workflows, or align with providers seeking compassionate use options.

Talk to Our Team Explore Programs