BTG Issued With Rejection Confirmation For Elevair Coil System By The FDA

The US Food & Drug Administration has rejected a premarket application by BTG PLC for Elevair Endobronchial Coil system. Elevair is currently under development for treatment of a type of lung condition called emphysema.

Shares responded with a slump

Following the announcement on Thursday, BTG shares dropped 2.8% to trade at 510.50 pence in the morning hours. The company is marketing Elevair in the EU under the brand name PneumRx Coils. It is a coil that is carefully implanted into the lungs of a person suffering from emphysema. The coil is used to keep the airways open when the patient breathes out. This is intended to prevent the airways from collapsing. The device works by reducing lung volume.

The device had been assessed, tested and examined for more than a year. This included four years of follow-ups on 315 patients.

In the announcement, the drug maker said it will go back to the drawing board so as to explore the options available for Elevair. The company promised to give an update to its shareholders and customers on the way forward.

An advisory committee had advised FDA to reject the treatment

Earlier in June, the Anesthesiology & Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee of the FDA had recommended not to approve BTG’s Elevair emphysema treatment. despite claims that Elevair is very effective in patients and that its benefits are heavier than the risks. The panel however did establish that the product is safe for use.

Although the recommendation was non-binding, it was considered by the FDA in making its final determination. At the time, the company said that it was optimistic that Elevair could play an important role in the management of the condition. The company says it is committed to offering additional data from the clinical studies so as to support its evidence.

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