Specialist healthcare group BTG received some bad news overnight from an advisory committee to the US drug regulator, which voted against the approval of its treatment for severe emphysema.
The US Food & Drug Administration's anaesthesiology and respiratory therapy devices panel of the Medical Devices Advisory Committee did not give their backing to the approval of the Elevair endobronchial coil system for the treatment of people with severe emphysema, known as PneumRX Coils in Europe.
The coils are designed to be permanently implanted in the most emphysema-damaged parts of the lung to allow more efficient contraction that helps assist the breathing cycle.
While the panel voted in 7-5 in favour of the statement that there is reasonable assurance that Elevair is safe for use in patients who meet the criteria specified in the proposed indication, while considering the additional procedures needed to maintain effectiveness, the rest of the votes went against the company.
The panel voted 7-5 against the statement that there is reasonable assurance that Elevair is effective for use in patients who meet the criteria specified in the proposed indication and 8-3 against the statement that the benefits outweigh the risks for use in patients who meet the criteria specified in the proposed indication.
This non-binding recommendation will be considered by the FDA in its ongoing review of PneumRx's pre-market approval application for Elevair, which is expected to conclude in late summer 2018.
BTG said it will continue to work with the FDA during its review process and will seek to address the specific concerns raised by the panel, and generally in the US, plans to continue to work with the FDA and "key opinion leaders" on the optimal next steps to support the introduction of this therapy there.
"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 FTSE 250 company said.
In the EU, the company has initiated the Elevate study that is designed to support patient selection and market development.
Broker Peel Hunt expected PneumRX to generate EU sales of $1.8m in 2019, $2.2m in 2020 and $3m in 2021 out of total group revenues of $820m, $765m and $787m respectively.