FDA application for new drug in 2018

Amber Salzman, Ph.D., President and CEO of Adverum Biotechnologies Inc., in the company’s financial results for the third quarter of 2017:

“We continue to make progress advancing our gene therapy programs to reach our goal of transforming Adverum into a clinical-stage company by the end of this year. Looking ahead, we plan to file an Investigational New Drug application for HAE with the FDA in the second half of 2018. We are well positioned and well capitalized to accelerate the development of our pipeline of novel gene therapies in 2018.”

ADVM-053 is the Adverum gene therapy product candidate designed for the treatment of patients with HAE. ADVM-053 is an AAV based gene transfer vector that aims to provide persistent levels of human C1-esterase inhibitor (C1-INH) to potentially correct the deficiency state that can lead to life threatening attacks.
(Source: Adverum)

2017-11-10T01:00:52+00:00