Promising Innovative Medicine Designation (PIM) issued from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for Rexmyelocel-T for the treatment of critical limb ischemia (CLI) based on Phase II data. PIM Designation constitutes Step 1 of the Early Access to Medicines Scheme (EAMS). EAMS aims to give patients access to medicines that do not yet have a marketing authorisation but meet a medical need that is currently not being met. The EAMS is primarily aimed at medicines that have completed Phase III trials, but may be applied to completed Phase II trials in exceptional circumstances.
PIM Designation (Step 1) is an early indication that a medicinal product is a promising candidate for the EAMS, in the treatment, diagnosis or prevention of life-threatening or seriously debilitating conditions with unmet need. Step 2 of the EAMS involves a Scientific Opinion from the MHRA, which the risks and benefits of the medicine based on data gathered from the patients who will benefit from the medicine. The opinion supports the prescriber and patient to make a decision on whether to use the medicine before its licence is approved. Rexgenero intends to file for a Scientific Opinion (Step 2) under the EAMS by the end of 2016.