Abeona Therapeutics Gets FDA Feedback for EB-101 BLA
By Chris Wack
Abeona Therapeutics said Friday that it received feedback from
the U.S. Food and Drug Administration, in which it gained the FDA's
alignment on the data required to establish retroviral vector
comparability, a critical chemistry, manufacturing and controls
component for the EB-101 Biologics License Application.
As part of the package, the FDA requested additional assay data
to establish comparability between retroviral vector sourced from
Indiana University and retroviral vector manufactured in-house at
Abeona, both of which have been used in the EB-101 clinical
The company said it has the necessary reagents in-house to
promptly generate the requested data. To allow the FDA the
necessary time to review the requested retroviral vector data,
Abeona has requested that its pre-BLA meeting date for EB-101 be
rescheduled for August.
The Company expects to file its BLA for EB-101 in the third
quarter of 2023.
Write to Chris Wack at firstname.lastname@example.org
(END) Dow Jones Newswires
June 09, 2023 07:53 ET (11:53 GMT)
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