Sanofi Granted FDA Priority Review for Potential Treatment of Rare Gaucher Disease

MT Newswires Live
05/28

Sanofi (SNY) has been granted US Food and Drug Administration priority review for a new drug application for venglustat for the treatment of type 3 Gaucher disease, a rare disorder, the company said Thursday.

The application is backed by data from a phase 3 study in which venglustat met both its primary endpoints and three out of four key secondary endpoints, the drugmaker said.

The target action date for the FDA decision is November 25, the company said.

Gaucher disease results in an abnormal buildup of sugar-and-fat molecules in the spleen, liver, bone marrow, and lungs, potentially causing neurological and cognitive challenges.

Sanofi will pursue more global regulatory filings for venglustat this year, it said.

免责声明:投资有风险,本文并非投资建议,以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请,作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考,不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证,投资者应自行研究并在投资前寻求专业建议。

热议股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10