Posted by Michael Wonder on 03 Sep 2020
U.K. MHRA grants meeting to CytoDyn to discuss fast track approval of leronlimab for COVID-19 patients
2 September 2020 - U.S. FDA schedules type A meeting with CytoDyn to discuss biologic license application filing for HIV.
CytoDyn announced today the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. Government requested a meeting with CytoDyn on 9 September 2020 to discuss the Company’s request for fast track approval of leronlimab to treat COVID-19 patients with mild to moderate symptoms based upon the trial’s top-line report and additional eIND data.
On the suggestion of the MHRA, CytoDyn will submit its current Phase 3 CD12 study for severe-to-critical COVID-19 patients in the UK to the Urgent Public Health (UPH) Research scheme to receive possible financial support from the trial sites and the government, if the UPH deems the Company’s CD12 trial an urgent health issue.
