FDA Extends Marketing Exclusivity for INOMAXÂ®
CLINTON, N.J., Jan. 5, 2011 /PRNewswire/ — Ikaria, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted INOMAXÃ‚® (nitric oxide) for inhalation an additional six months of marketing exclusivity, known as “pediatric exclusivity.” The action extends exclusivity for INOMAX from January 2013 to July 2013. This decision was based on data submitted from three clinical trials of INOMAX in pre-term infants at risk for bronchopulmonary dysplasia (BPD), a serious respiratory condition resulting from lung injury.
Data from three large, multi-center, double-blind, placebo-controlled clinical trials examining the efficacy and safety of INOMAX in pre-term infants less than or equal to 34 weeks gestational age were submitted to the FDA. Although the safety and tolerability of INOMAX has been shown in these trials, substantial evidence of efficacy has not been demonstrated. Therefore, Ikaria continues to study the efficacy of INOMAX for the prevention in BPD in pre-term infants through its Phase III clinical trial, which commenced in December 2009. INOMAX is not indicated for the prevention of BPD in pre-term infants.
INOMAX is indicated for the treatment of hypoxic respiratory failure, or HRF, in term and near-term (greater than 34 weeks) infants. HRF occurs when the cells in the body are unable to receive enough oxygen, and is a life-threatening condition for newborns. INOMAX helps critically ill newborns breathe more effectively by dilating the blood vessels of the lungs, which improves oxygen uptake and maximizes oxygen supply to the tissues of the body. Use of INOMAX reduces the need for extracorporeal membrane oxygenation (ECMO), a highly-invasive and expensive surgical procedure in which an infant’s blood is mechanically oxygenated by connecting the newborn to a heart-lung machine.
INOMAX is delivered as part of a comprehensive offering known as INOtherapyÃ‚®. In addition to INOMAX, INOtherapy includes use of Ikaria’s proprietary, FDA-cleared drug-delivery system, all related disposable items, distribution, emergency delivery, technical and clinical assistance, quality maintenance, on-site hospital training, and 24/7/365 customer service.
INOMAXÃ‚® is a vasodilator, which, in conjunction with ventilator support and other appropriate agents, is indicated for the treatment of term and near-term (greater than 34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.
INOMAX should not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood. Abrupt discontinuation of INOMAX may lead to a worsening condition. Methemoglobinemia is a dose-dependent side effect of inhaled nitric oxide therapy. Nitrogen
dioxide (NO2) forms rapidly in gas mixtures containing nitric oxide and oxygen, and therefore may cause airway inflammation and damage. Methemoglobin, NO2, and FiO2 should be monitored during nitric oxide administration.
Please see attached prescribing information. For additional more information about INOMAX, please visit www.inomax.com.
About Ikaria, Inc.
Ikaria, Inc. is a biotherapeutics company focused on developing and commercializing innovative therapeutics and interventions designed to address the significant unmet needs of critically ill patients. The company’s lead product is INOtherapyÃ‚®, an all-inclusive offering of drug product, services and technologies. INOMAXÃ‚® (nitric oxide) for inhalation, the drug included in the INOtherapy offering, is the only FDA-approved drug for the treatment of hypoxic respiratory failure associated with pulmonary hypertension in term and near-term infants. INOtherapy also is marketed in Puerto Rico, Canada, Australia, Mexico and Japan. Ikaria acquired the North American and Australian rights to LUCASSINÃ‚® (terlipressin), a potential treatment for hepatorenal syndrome Type 1, as well as the exclusive worldwide license to IK-5001, a potential treatment for preventing cardiac remodeling and subsequent congestive heart failure following acute myocardial infarction. The company also has a number of investigational compounds in development. Ikaria is headquartered in Clinton, NJ, with research facilities in Seattle, WA and Madison, WI, and a manufacturing facility in Port Allen, LA. Please visit www.ikaria.com.
SOURCE Ikaria, Inc.