Mallinckrodt’s INOmax Approved in Australia for Adults with Perioperative PH and Heart Surgery

The health regulatory agency for Australia has approved Mallinckrodt Pharmaceuticals‘ INOmax (nitric oxide) gas for inhalation as a treatment for adult patients with perioperative pulmonary hypertension (PH) in combination with cardiovascular (heart) surgery.

INOmax is a vasodilator inhalation device that works by widening and relaxing blood vessels in the lungs, which decreases pulmonary arterial pressure, improves blood circulation, and eases breathing. The device is used together with ventilator support or other appropriate agents.

INOmax is already approved in Australia for treating peri- and post-operative PH in combination with heart surgery in young patients — from birth to age 17. The regulatory agency, the Therapeutic Goods Administration (TGA), also approved it for treating hypoxic respiratory failure (HRF), a potentially life-threatening complication of PH, in newborns or near-term babies with more than 34 weeks gestation.

With this latest approval, INOmax is now available in Australia for all patients, from infants through adults, with perioperative PH combined with heart surgery.

“This expanded approval of INOmax in Australia for cardiovascular surgery in adults is an important milestone for Mallinckrodt, confirming the benefit this therapeutic option can bring to perioperative pulmonary hypertension patients,” Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt, said in a press release.

“We continue to focus on improving outcomes for underserved patients with severe and critical conditions, and this is an example of those efforts making a difference. There is a tremendous global need for therapies for patients undergoing cardiac surgery. We look forward to helping meet these needs,” Romano said.

INOmax was also approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of babies born with more than 34 weeks gestation who have respiratory problems associated with PH.

In the European Union, INOmax is approved for patients of all ages undergoing heart surgery who developed PH, to improve heart function and reduce blood pressure in the lungs.

In Japan, the Ministry of Health, Labour and Welfare (MHLW) had approved INOmax, marketed there as INOflo/INOvent, for treating both HRF and perioperative PH, together with heart surgery, in patients of all ages.