Posted by Michael Wonder on 06 Apr 2017
Prometic completes the filing of its plasminogen biologics license application with the U.S. FDA
5 April 2017 - Prometic Life Sciences announced today that it has completed the filing of its plasminogen biologics license application with the U.S. FDA for the treatment of patients with plasminogen congenital deficiency.
Prometic’s plasminogen replacement therapy has been granted orphan drug and fast track designations by the FDA. Prometic has also applied for a paediatric designation as its research demonstrates that the most serious and life-threatening manifestations of the congenital plasminogen deficiency occur most commonly in paediatric patients. Moreover, data gathered over a very large sample size in the USA (more than 900 million medical claims), enabled the Corporation to provide evidence to the FDA that an estimated 2,100 patients have sought medical care and treatment for plasminogen deficiency in the USA over a nine month period (between Q4 2015 and Q3 2016) with such requirements occurring disproportionately more often in patients aged 18 years old and younger.
“The completion of the plasminogen application filing is a significant milestone achievement for Prometic and, eventually, for all the patients who suffer from the complications associated with this deficiency”, stated Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. “We look forward to launching plasminogen in the USA in Q4 2017 and providing a cost effective therapy for this serious unmet medical need”.
