EMED Technologies Corporation announced the SCIg60 Infusion System has been granted expanded indications as the only Immune Globulin Subcutaneous (Human) mechanical pump infusion system cleared by the U.S. FDA.
Since its initial efforts in the SCIg market over a decade ago, EMED has been working with Global Pharma leaders to provide infusion platforms for administration of human plasma-derived immunoglobulin biologics. In this most recent FDA clearance, Shire was directly involved in the selection of infusion criteria required by Shire's biologics and endorsed EMED's 510(k) premarket clearance submission accordingly.
"We are particularly proud of our joint undertaking with Shire, the world leader in rare diseases and highly specialized conditions,” Paul Lambert, CEO of EMED said. “The opportunity to work along with Shire to optimize Cuvitru and Gammagard delivery protocols has been collaborative and rewarding."
The SCIg60 system's new FDA clearance relied upon drug-device compatibility validation of the SCIg60 with the indicated human Iggs in support of the expanded indications for use, that now include subcutaneous infusion of the following:
- CUVITRU Immune Globulin Infusion (Human) 20% (manufactured by Shire)
- Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Shire)
- Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring)
This most recent expansion of indications has resulted from EMED's interaction with the FDA in the context of increasingly stringent regulations for infusion devices. The FDA created a new device code "PKP" to classify and regulate infusion systems for immunoglobulins.