Bayer Subsidiary Gets Fast-track Status for Parkinson's Treatment in U.S.
By David Sachs
A Bayer-owned drug developer received special fast-track status from U.S. regulators for its Parkinson's disease treatment following positive phase-1 trials.
The German pharmaceutical company said Thursday that BlueRock Therapeutics' cell therapy candidate, bemdaneprocel, received the Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration.
The special status, which can speed up the treatment's delivery to market, came after a phase-1 clinical trial found the treatment was well-tolerated in patients with no major safety issues through 18 months.
"The RMAT designation for bemdaneprocel underscores the potential of this candidate to fundamentally change the way we think about Parkinson's disease care," said Christian Rommel, head of research and development at Bayer's pharmaceutical division.
Write to David Sachs at david.sachs@wsj.com
(END) Dow Jones Newswires
May 30, 2024 03:11 ET (07:11 GMT)
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