Regeneron Says Application for Expanded Use of Eylea Accepted for FDA Priority Review

MT Newswires Live
04/17

Regeneron Pharmaceuticals (REGN) said Thursday that its supplemental biologics license application for Eylea HD 8 mg injection has been accepted for priority review by the US Food and Drug Administration, with a decision expected by Aug. 19.

The company said it is seeking approval for Eylea, or aflibercept, to treat macular edema following retinal vein occlusion and to expand Eylea HD's dosing schedule to include every 4-week dosing across approved indications.

The submission is backed by data from a phase 3 trial, which showed that patients who received Eylea HD every 8 weeks achieved similar vision outcomes compared with those receiving the drug every 4 weeks, the company said.

免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。

熱議股票

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