A international phase 3 study of Lupuzor for the treatment of systemic lupus erythematosus
Latest Information Update: 14 Jul 2021
At a glance
- Drugs Forigerimod (Primary)
- Indications Systemic lupus erythematosus
- Focus Registrational; Therapeutic Use
- 24 Jun 2021 According to an ImmuPharma media release, company will provide an update as soon as Avion has received the written response from the FDA and advised ImmuPharma of the next steps and timetable towards commencing the Phase 3 trial this year.
- 24 Jun 2021 According to an ImmuPharma media release,as noted in our previous announcement of 9 February, this is the final guidance meeting at which the FDA will review the proposed methodology of the pharmacokinetic ("PK") study. This study was requested by the FDA as part of the new optimised international Phase 3 trial of Lupuzor™ in systemic lupus erythematosus.
- 24 Jun 2021 According to an ImmuPharma media release, company, announces that its US Lupuzor™ partner, Avion Pharmaceuticals ("Avion") has received a positive response from the US Food & Drug Administration ("FDA") for a "Type C" meeting. The FDA has advised that they do not require a formal face to face meeting and will provide their written response to Avion approximately by the end of July 2021.