Savara's inhaled GM-CSF drug molgradex is qualified as FDA breakthrough drug
-
Last Update: 2019-12-31
-
Source: Internet
-
Author: User
Search more information of high quality chemicals, good prices and reliable suppliers, visit
www.echemi.com
Savara Inc is a clinical stage US biopharmaceutical company dedicated to the development and commercialization of innovative therapies for severe or life-threatening rare respiratory diseases Recently, the company announced that the U.S Food and Drug Administration (FDA) has granted molgradex breakthrough drug qualification (BTD), a recombinant human granulocyte macrophage colony stimulating factor (GM-CSF) inhalation preparation for the treatment of autoimmune alveolar proteinosis (APAP) BTD is a new drug review channel established by FDA in 2012 It aims to accelerate the development and review of new drugs for the treatment of serious or life threatening diseases and there is preliminary clinical evidence that the drug can substantially improve the condition compared with existing treatment drugs The drugs that obtain BTD can receive more close guidance, including FDA senior officials, during the research and development, so as to guarantee to provide patients with new treatment options in the shortest time FDA awarded molgradex BTD based on data from the critical phase III clinical study impala The study assessed the efficacy and safety of molgradex in the treatment of APAP, and data were recently presented at the oral meeting of the European Respiratory Society (ERs) International Conference 2019 in Madrid, Spain.
This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only.
This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of
the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed
description of the concern or complaint, to
service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content
will be removed immediately.
![9-[3-Chloro-5-(phenanthren-9-yl)phenyl]phenanthrene / 1369431-34-4](https://file.echemi.com/fileManage/upload/goodpicture/20241028/9-3-chloro-5-phenanthren-9-ylphenylphenanthrene-1369431-34-4_b20241028151130118.jpg)
