Efalizumab

Overview

Humanized IgG1 kappa isotype monoclonal antibody that binds to human CD11a. Efalizumab has a molecular weight of approximately 150 kilodaltons and is produced in a Chinese hamster ovary mammalian cell expression system in a nutrient medium containing the antibiotic gentamicin. The FDA approved efalizumab in 2003. It was later withdrawn in 2009 due to a potential risk of progressive multifocal leukoencephalopathy (PML).

Indication

For the treatment of adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.

Associated Conditions

Moderate to Severe Chronic Plaque Psoriasis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pilot Trial to Assess Effect of CNI Conversion of Efalizumab on T Reg Cells	2008/10/22	NCT00777400	Phase 1	Withdrawn	University of California, San Francisco
Efalizumab in the Treatment of Alopecia, Phase II	2008/09/04	NCT00746980	Phase 2	Withdrawn	Northwestern University
TRUST Study: Raptiva ® in Hand & Foot Psoriasis	2008/08/22	NCT00739882	Phase 4	Terminated	Merck KGaA, Darmstadt, Germany
Beta Cell Rescue in New Onset Type 1 Diabetes With Efalizumab	2008/08/20	NCT00737763	Phase 2	Withdrawn	Emory University
A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation	2008/08/07	NCT00729768	Phase 2	Withdrawn	Genentech, Inc.
Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis	2008/06/30	NCT00707070	Phase 4	UNKNOWN	Universita di Verona
ChangE From Any Systemic psoriasiS therapY to Raptiva	2008/06/16	NCT00697593	Phase 4	Terminated	Merck KGaA, Darmstadt, Germany
Combined aPproach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study	2008/05/13	NCT00676559	Phase 1	Withdrawn	Johns Hopkins University
Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes	2008/05/06	NCT00672204	Phase 1	Terminated	University of Minnesota
A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp	2008/04/30	NCT00669214	Phase 4	Completed	Genentech, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
RAPTIVA	emd serono, a division of emd inc., canada	02272504	Powder For Solution - Subcutaneous	150 MG / VIAL	10/26/2005

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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