Meeting Pharmaceutical Standards For Product Approval
The INTERCEPT Blood System was extensively evaluated prior to product approval to establish the safety and efficacy of both amotosalen and amotosalen-treated platelets and plasma. Consistent with requirements for new pharmaceutical drugs, results of pre-clinical through Phase I through III clinical testing were submitted to European authorities for consideration. Ongoing hemovigilance trials will continue to evaluate the performance of the products in routine use.
Extensive Preclinical Characterization of Amotosalen and Photochemical Treatment Process
Preclinical studies were performed using both amotosalen alone and illuminated mixtures of amotosalen, photoproducts, and platelets or plasma. Amotosalen was shown to photodegrade into well-characterized species and is rapidly excreted following transfusion.1,2 Preclinical safety studies demonstrated high safety margins for amotosalen with no toxicologically relevant effects for either INTERCEPT Platelets or INTERCEPT Plasma.2
| Table 1: Scope of Pharmacokinetic & Toxicology Studies for INTERCEPT Platelets & Plasma | |
| Types of Studies Performed | |
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Phase I Through III Clinical Trials for Controlled Study in Human Subjects
Following successful completion of the early clinical studies, multiple Phase III trials were performed to evaluate each product’s therapeutic performance and safety in patient populations requiring transfusions. Treated platelets and plasma were similar to conventional products for control of bleeding; safety profile of treated products was not different from conventional platelets and plasma.
| Table 2: Clinical Experience with INTERCEPT Platelets and Plasma | ||
| Product | Phase I & II Trials | Phase III Trials |
| Platelets | 4 trials 43 subjects |
4 trials / 811 patients ~3,700 INTERCEPT units |
| Plasma | 3 trials 42 subjects |
3 trials / 203 patients ~5,000 INTERCEPT units |
Compliance with Regulatory Requirements for European Approval
For both INTERCEPT Platelets and Plasma, the Medical Device Design Dossiers submitted for European approval included full Drug Dossiers to support safety and efficacy of the amotosalen component. Regulatory authorities concluded that INTERCEPT Platelets and Plasma are not clinically different from untreated products and may be prescribed and transfused in accordance with standard infusion methods.3
| Table 3: Regulatory Status of INTERCEPT | |
| Regulatory Status | |
| Europe | The INTERCEPT Blood Systems for platelets and plasma are CE marked and produced to ISO 13485 Quality standard. |
| France | INTERCEPT Platelet and Plasma product characteristics approved by Afssaps and published in Journal Officiel. |
| Germany | First blood center marketing authorization approved by PEI for INTERCEPT Platelets in 2007. |
Ongoing Hemovigilance Studies
Over 30,000 INTERCEPT Platelet transfusions have already been evaluated as part of an ongoing hemovigilance program.
References:
1. V Ciaravino et al., Vox Sanguinis 2003; 85:171-82.
2. V Ciaravino, et al. Hum Exp Toxicol. 2001; 20: 533-50.
3. Supported by approved technical documentation for INTERCEPT Platelets and INTERCEPT Plasma.
Use of the INTERCEPT Blood System in the United States is limited by Federal law to investigational use. If you are a resident of the U.S., please click here.
The information on this site is not country-specific, and may contain information that is outside the approved indications for the country in which you are located. The INTERCEPT Blood System is CE marked for use with platelets and plasma.
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