FDA Grants VERO Biotech Expanded Access Emergency Use of GENOSYL DS for COVID-19 Patients

VERO Biotech announced the U.S. Food and Drug Administration (FDA) has granted "expanded access emergency use" allowing its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL® DS, to immediately be used for the treatment of cardiopulmonary symptoms associated with COVID-19. GENOSYL (nitric oxide) gas, for inhalation, was recently approved by the FDA for the treatment of persistent pulmonary hypertension of the newborn (PPHN) and is the only tankless inhaled nitric oxide device available in the US.

Application of VERO's tankless inhaled nitric oxide system is valuable during a time of crisis when hospital beds and ventilators are in short supply. The ability to have a portable device in either the hospital or home setting enables healthcare providers the flexibility to treat patients with iNO in various settings, and give patients more access to the care they need.

"In this time of a global pandemic and public health crisis, it is critical to explore all potential options for treating both the novel coronavirus and its associated cardiopulmonary conditions," said Brent V. Furse, President and CEO, VERO Biotech. "Inhaled nitric oxide may provide important benefits and we at VERO Biotech intend to expedite and expand our research in this critical area. The application of home use of iNO—which was not been logistically viable until the approval of a tankless and portable system—may itself also play a role in limiting current demand for hospital beds and ventilators by patients suffering from symptoms due to COVID-19."

VERO Biotech is also working with global academic experts in infectious and cardiopulmonary diseases to evaluate the potential clinical benefits of GENOSYL in treating pulmonary manifestations of COVID-19.

GENOSYL is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

GENOSYL is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood. (See below for additional Important Safety Information.)

VERO Biotech's GENOSYL Delivery System (DS) is a compact and user-friendly nitric oxide delivery system, that will not only enable hospitals to reduce logistical burden as compared to the cumbersome tank-based systems currently available, but could provide greater patient access to this potentially life-saving drug.

Nitric oxide is a molecule proven to play a role in a broad array of biological functions. In the airways, nitric oxide targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs and is used in adult respiratory distress syndrome and persistent pulmonary hypertension of the neonate.

Prior to the approval of the GENOSYL system, the only way to provide iNO was via large, pressurized gas cylinders and complicated delivery systems.

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