BTG said that a US Food and Drug Administration (FDA) advisory committee panel has voted against the approval of its Elevair Endobronchial Coil System for the treatment of people with severe emphysema.
The committee has recommended additional procedures to prove the effectiveness of the lung implant in treating the condition.
A majority of the panel members felt that the lung implant developed by the UK-based healthcare company’s subsidiary PneumRx is safe to be used in patients who meet the criteria specified in the proposed indication.
The FDA panel wasn’t convinced though that there is reasonable assurance that the Elevair lung implant is effective to be used in patients for the proposed indication.
Further, most of the panel members opined that the benefits of Elevair did not outweigh the risks for use in such patients.
Although the panel’s recommendation is non-binding, the FDA will consider it before making a decision on PneumRx’s Pre-market Approval (PMA) application for the lung implant. A decision from the regulator is expected to come in late summer 2018, said BTG.
The company said that it will look to address the specific concerns raised by the FDA panel while continuing to work with the US regulator during the review process.
According to the healthcare firm, currently, there are limited treatment options available for patients with severe emphysema.
The company, in a statement, said: “BTG continues to believe that Elevair (called the PneumRx Coils in the EU) 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.”
Further, it revealed that in the European Union, it has launched the Elevate study, which is expected to support patient selection and market development of the Elevair Endobronchial Coil System.
In the US, the company said that it will continue to work with the FDA and with major opinion leaders and others on the optimal next steps towards introducing the lung implant therapy in the country.
Based in the US, PneumRx, which is a manufacturer of medical devices focused on interventional pulmonology, was acquired by BTG in a deal worth up to $475m.