The US Food and Drug Administration (FDA) has granted fast track designation to Infirst Healthcare’s haemoglobin spray, Granulox, for the treatment of diabetic foot ulcers (DFUs).
Approval
“Chronic, non-healing DFUs are a major health problem. If approved by the FDA, Granulox haemoglobin spray could contribute to improving outcomes for many patients with DFUs as well reducing the significant, associated burden of healthcare costs,” said Manfred Scheske, CEO of Infirst Healthcare.
Granulox works by increasing the levels of oxygen at the wound bed, thus speeding up the rate of healing as well as reducing pain. It is approved as a class III medical device in the European Union and marketed for the treatment of DFUs, venous leg ulcers and pressure ulcers. Infirst Healthcare has exclusive US commercialisation rights for the haemoglobin spray via a licence agreement with Sastomed — a German biotechnology company.
“Granulox has been filed as an investigational new product with the FDA. We are currently in discussions regarding specific manufacturing requirements as well as finalising the exact design of a phase III clinical development programme,” continued Scheske. “We are now looking to commence discussions with potential partners and investors to support us in expediting the completion of this process — to ensure the treatment is available to patients as quickly as possible.”
