The European Commission (EC) has awarded orphan medicinal product designation to Austin-based pharmaceutical company Lung Therapeutics, Inc.‘s LTI-01 for the treatment of empyema as a complication from pneumonia. The decision was made after a positive opinion granted by the Committee for Orphan Medicinal Products (COMP), which is part of the European Medicines Agency (EMA).
Orphan drug status from the European authorities grants Lung Therapeutics up to 10 years of marketing exclusivity for LTI-01 in all the countries within the European Union after it receives marketing approval, as well as other benefits, such as EU-funded research, protocol assistance, and fee reductions. The company had already been granted the equivalent designation by the U.S. Food and Drug Administration, which gives it seven years of market exclusivity after marketing approval in the United States.
“Having consulted on other EU orphan drug submissions in the past, I know how challenging the process can be,” explained Andrew P. Mazar, the co-founder and consulting head of product development at Lung Therapeutics, in a recent press release. “Accomplishing this important milestone is a significant achievement.”
“In addition to 10 years of market exclusivity, EC orphan drug designation provides regulatory and financial incentives to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union, and where no satisfactory treatment has been available. We now have the potential to help patients around the world who previously had few if any viable options,” Mazar added.
The injectable, fibronolytic drug LTI-01 is among Lung Therapeutics’ portfolio dedicated to addressing unmet medical needs in lung diseases, and facilitates the removal of scar tissue surrounding the lungs in order to improve fluid drainage and reduce the risk of bleeding and other complications. In addition, the drug is expected to avoid the need for both costly surgery and other treatments.
“We are pleased that the European Commission has recognized the potential of LTI-01 to improve patient outcomes in the treatment of empyema in Europe,” said the CEO of Lung Therapeutics, Brian Windsor, Ph.D. “This designation, along with the orphan drug status we have already received in the U.S. from the FDA, underscores the unmet medical need LTI-01 addresses for patients suffering from empyema.”