An advisory committee has told US regulators to reject a pre-market approval application for BTG PLC’s (LON:BTG) severe emphysema treatment.
While the panel felt Elevair was safe for use, it wasn’t convinced by the product’s effectiveness or that the possible benefits outweighed the risks.
READ: BTG slumps as it takes £150mln impairment for PneumRx Coils in full-year results
As a result, it has told the US Food and Drug Administration not to approve the treatment, which is also known as PneumRx Coils in Europe.
Shares fell 6.3% to 511p at the opening bell on Friday.
The recommendation is non-binding but will be considered by the FDA as part of its ongoing review of Elevair, which is expected to conclude towards the end of summer.
BTG said it will continue to work with regulators and address any concerns raised by the committee.
“There are few treatment options for patients with severe emphysema. BTG continues to believe that Elevair has a role to play in the management of these patients and is committed to generating additional clinical data to support the existing body of evidence,” the statement said.