Phase III efficacy trial of BCX-7353 for the treatment of hereditary angioedema.
Phase of Trial: Phase III
Latest Information Update: 07 Nov 2017
At a glance
- Drugs BCX 7353 (Primary)
- Indications Hereditary angioedema
- Focus Registrational; Therapeutic Use
- Sponsors BioCryst Pharmaceuticals
- 07 Nov 2017 According to a BioCryst media release, this trial is expected to support NDA and MAA filings in 2019.
- 08 Sep 2017 New trial record
- 05 Sep 2017 According to a BioCryst media release, company intends to meet with the US FDA and European Medicines Agency (EMA) during the fourth quarter of 2017 to finalize the Phase III program required to support regulatory submissions in the US and Europe. This trial is expected to be initiated in the first quarter of 2018.