ProMetic Life Sciences Inc. reported that the U.S. Food and Drug Administration (FDA) has granted a Fast Track designation to ProMetic for its plasminogen drug candidate, currently in a phase 2/3 clinical trial in patients suffering from congenital Plasminogen deficiency.
Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions that fill an unmet medical need, with the main objective of getting important new drugs to the patient earlier. To gain Fast Track designation, Plasminogen therapy demonstrated a strong rationale for its use as a treatment for a serious, often morbid and potentially fatal, condition as well as for treating an unmet medical need which previously largely relied on repeated surgeries to remove recurring obstructive and debilitating lesions.
“To date, our plasminogen therapy has been well tolerated and initial compassionate use treatments have shown a rapid response in lesion resolution and have helped avoid the need for surgery”, said Mr. Pierre Laurin, ProMetic’s CEO. “This was recently evidenced with a patient who, under an expanded access protocol, avoided an 8th surgery to his kidney by opting for ProMetic’s plasminogen infusion therapy instead. Fast Track designation is an important milestone and we continue to work closely with the FDA to expeditiously bring our Plasminogen to patients with congenital Plasminogen deficiency”, added Mr. Laurin.
In addition to allowing for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, a drug that receives a Fast Track designation is also eligible for a Rolling Review of the Biologic License Application (BLA) by the FDA, allowing the review to proceed more efficiently and facilitating earlier drug approval and access by patients.
ProMetic’s Plasminogen was also granted Orphan Drug Designation by the FDA and the European Commission for the US and the European markets respectively. As an orphan drug designated product, ProMetic’s Plasminogen is also eligible for priority review of the BLA, which reduces the standard review period by 6 months and so also speeds the time to availability of this important medicine on the market.
