EspeRare’s ER-004 Receives the US FDA’s Breakthrough Therapy Designation for Prenatal Treatment of XLHED

 EspeRare’s ER-004 Receives the US FDA’s Breakthrough Therapy Designation for Prenatal Treatment of XLHED

Dermelix Collaborates with EspeRare to Co-develop and Commercialize DMX-101 for XLHED

Shots:

  • The BT designation is provided on three results from three XLHED subjects with a course of ER-004 intra-amniotic injections during the third trimester of pregnancy while the results were published in NEJM and showed profound and life-changing effects on infants
  • The US FDA’s BT designation is granted to expedite the development and review of drugs for serious or life-threatening conditions allowing the program to benefit from all the FDA’s fast-track program feature
  • In H2’21, EspeRare to enroll patients for the study which is also benefited with Fast Track and ODD and has also received the EMA’s PRIME designation and ODD

Click here to read full press release/ article | Ref: PRNewswire | Image: PharmaWorld

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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