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Xbrane Biopharma Reports Update on the Ongoing P-III Xplore Study of Xlucane (biosimilar- ranibizumab)

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Xbrane Biopharma Reports Update on the Ongoing P-III Xplore Study of Xlucane (biosimilar- ranibizumab)

Shots:

  • Xlucane is still on track towards regulatory approval ahead of Lucentis’ patent expiration in EU July 2022. Despite the COVID-19- Xplore will continue the recruitment of new patients and treatment for patients currently in the study
  • Xbrane will ensure the safety participants in the P-III study as well as the integrity of study data during the COVID-19 by following EMA’s and FDA’s recommendations. The company has currently recruited ~60% of the planned 580 patients
  • Xbrane has agreed with the EMA and the FDA to submit MAA/ BLA- based on the interim read-out when last patient has reached month six in the treatment schedule. Xplore is expected to record its last patient by the end Q3’20

Click here to read full press release/ article | Ref: Xbrane | Image: Twitter


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