By webmin on
Phone
N/A
Email
ExpandedAccess@takeda.com
ClinicalTrials.gov URL
https://clinicaltrials.gov/ct2/results?cond=&term=&spons=takeda&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=d
Acknowledgement
3 business days
EA Page
https://www.takeda.com/what-we-do/access-to-medicines/pre-approval-access/
Sponsor
Ariad Pharmaceuticals
Millennium Pharmaceuticals, Inc.
Shire
EA Policies for Disease / Category

EXPANDED ACCESS TO INVESTIGATIONAL DRUGS

https://www.takedaoncology.com/medicines/expanded-access-to-investigational-drugs/

COVID-19 Information

Takeda Initiates Development of a Plasma-Derived Therapy for COVID-19 - Takeda is initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) to treat high-risk individuals with COVID-19. Hyperimmune globulins are plasma derived-therapies that have previously been shown to be effective in the treatment of severe acute viral respiratory infections and may be a treatment option for COVID-19. 

This research requires access to source plasma from people who have successfully recovered from COVID-19 or who have been vaccinated, once a vaccine is developed. These convalescent donors have developed antibodies to the virus that could potentially mitigate severity of illness in COVID-19 patients and possibly prevent it. BioLife Plasma Services, part of Takeda, has implemented a protocol for collecting plasma from healthy individuals who have recovered from COVID-19 to enable development of a potential therapy for COVID-19, made from human plasma. For more information, go to https://pub.s1.exacttarget.com/3xhgrthonqe?_ga=2.157390458.1771561704.1585853136-1731863841.1585853136

Global Plasma Leaders Collaborate to Accelerate Development of Potential COVID-19 Hyperimmune Therapy - Other companies involved in this alliance include CSL Behring, Octapharma, and Biotest AG

CoVIg-19 Plasma Alliance Builds Strong Momentum Through Expanded Membership and Clinical Trial Collaboration

Stage
Pre-clinical
Company Type
Early Onset Intervention
Late Onset Intervention
Expanded Access Listings

Treatment Protocol of Velaglucerase Alfa for Patients With Type 1 Gaucher Disease

Conditions
Gaucher Disease, Type 1

Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of theenzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB,glucocerebroside accumulates within macrophages leading to cellular engorgement,organomegaly, and organ system dysfunction. The purpose of this treatment protocol is toobserve the safety of velaglucerase alfa in patients with type 1 Gaucher disease who areeither treatment naive (newly diagnosed) or who are currently being treated with theEnzyme Replacement Therapy (ERT) imiglucerase.

Expanded Access Program of Ponatinib

Conditions
Chronic Myeloid Leukemia (CML)
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

This protocol will allow expanded access of ponatinib to patients ≥18 years with chronicmyeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblasticleukemia (Ph+ALL) who have failed all available treatment options.