15th Jun 2018 08:15
LONDON (Alliance News) - BTG PLC said Friday that the Anesthesiology & Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee of the US Food & Drug Administration has voted against recommending approving BTG's Elevair emphysema treatment.
The panel voted against the claim that Elevair is "effective for use in patients" and also against the claim that "the benefits of Elevair outweigh the risks".
The panel's recommendation against the treatment is non-binding but will be considered by the FDA as part of its ongoing review of Elevair. The review is expected to conclude "in late summer 2018", the company said.
BTG said that it will "seek to address" the panel's concerns while continuing to work with the FDA during the review.
Elevair, marketed as PneumRx Coils in the EU, is a type of coil that is implanted into the lungs of emphysema patients in order to hold open their airways when they exhale. This treatment is intended to prevent the airways from collapsing.
Shares in BTG were down 6.6% on Friday at 506.40 pence, the second worst performer in the FTSE 250 index.
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