June 15, 2018
Result of FDA Advisory Committee vote on Elevair™ for the treatment of severe emphysema
15 June 2018
BTG plc (LSE: BTG), the global specialist healthcare company, notes that the US Food & Drug Administration’s (FDA’s) Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee yesterday voted against the approval of the Elevair™ Endobronchial Coil System for the treatment of people with severe emphysema.
The Panel voted as follows: 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 (7-5 in favour); that there is reasonable assurance that Elevair™ is effective for use in patients who meet the criteria specified in the proposed indication (7-5 against); and that the benefits of Elevair™ outweigh the risks for use in patients who meet the criteria specified in the proposed indication (8-3 against and one abstention).
The Panel’s non-binding recommendation will be considered by the FDA in its ongoing review of PneumRx’s Pre-market Approval (PMA) application for Elevair™, which is expected to conclude in late summer 2018.
BTG will continue to work with the FDA during its review process and will seek to address the specific concerns raised by the Panel.
There are few treatment options for patients with severe emphysema. 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. In the EU, the company has initiated the ELEVATE study that is designed to support patient selection and market development. In the US, BTG will continue to work with the FDA and with key opinion leaders and others on the optimal next steps to support the introduction of this therapy into the US.
For further information contact:
Andy Burrows, VP Corporate & Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530 605
Stuart Hunt, Investor Relations Manager
+44 (0)20 7575 1582; Mobile: +44 (0)7815 778 536
Chris Sampson, Corporate Communications Director
+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178
Ben Atwell/Simon Conway
+44 (0)20 3727 1000
BTG is a global healthcare company focused on Interventional Medicine. Our innovative medical technology helps physicians treat their patients through minimally invasive procedures. We have a growing portfolio of products that advance the treatment of cancer, vascular conditions and severe emphysema. BTG’s Pharmaceuticals business provides products that help patients overexposed to certain medications or toxins. To learn more about BTG, please visit: btgplc.com.