FDA Unlikely to Approve LungFit PH System for PPHN by Year’s End
Beyond Air has announced that it is not expecting the U.S. Food and Drug Administration (FDA) to approve its LungFit PH device to treat persistent pulmonary hypertension of the newborn (PPHN) before the end of the year.
Beyond Air filed an application with the FDA in late 2020 requesting approval. However, “based upon our ongoing communications with the FDA, the Company no longer believes that the U.S. commercial launch of LungFit PH will take place prior to December 31, 2021,” the company stated in a press release. No further details were given.
“We commend the FDA for their continued commitment to provide us with a comprehensive review of our application,” said Steve Lisi, Beyond Air’s chairman and CEO. “We shall continue to collaboratively work with the FDA to approve LungFit PH.”
The company is expecting the LungFit PH device to receive the CE Mark in Europe in the first half of next year. The CE Mark is given by the European Commission to products that meet certain safety, health, and environmental protection requirements.
“The Beyond Air team continues to work towards our goal of bringing LungFit PH, the groundbreaking nitric oxide generator and delivery system, to NICUs [newborn intensive care units] across the United States and the world as soon as possible,” Lisi said.
PPHN is a potentially life-threatening condition that affects about 1 of every 1,250 newborns. It is characterized by high resistance against blood flow in the lungs, which can ultimately prevent a baby’s brain and body from getting enough oxygen.
The LungFit PH device works by generating nitric oxide gas from ambient air. Nitric oxide, or NO, is a vasodilator — a substance that triggers blood vessels to relax and get wider, thereby lowering blood pressure.
NO is commonly used to treat newborns with pulmonary hypertension, but the traditional use of NO has required large, pressurized cylinders to store the NO gas. Since it can make NO out of surrounding air, the LungFit PH system aims to make NO treatment more convenient and accessible by doing away with the need for the traditional bulky equipment.
Beyond Air is also developing LungFit PH to help treat certain types of lung infections, including COVID-19.