The US Food and Drug Administration (FDA) has cleared the expanded access programme (EAP), submitted by Pluristem Therapeutics, for the use of PLX-PAD cell treatment in patients with critical limb ischaemia (CLI).
FDA approved
An EAP enables the use of an investigational medical product outside of clinical trials and is usually granted in cases where patients are unsuitable for inclusion under the study protocol and the patient’s condition is life-threatening with an unmet medical need.
“This is a true vote of confidence by the FDA in our cell therapy and a landmark achievement for Pluristem and its shareholders. It gives us the ability to begin treatments using our cell product, offering treatment to certain CLI patients who have poor therapeutic options, while also collecting real-world data alongside our ongoing Phase III clinical study,” said Yaky Yanay, co-CEO and president of Pluristem. “We are hopeful that the FDA may also allow us to be compensated for the costs of treatment, which can support our work developing effective cell therapies for millions of patients worldwide.”
As part of the cleared programme, Pluristem’s PLX-PAD cell therapy will be available to a limited number of Rutherford Category 5 CLI patients in the US who are unsuitable for revascularisation and cannot take part in the company’s ongoing Phase III clinical study, which is currently enrolling patients in the US and Europe.