Orphan medicinal products are for diagnosing, preventing or treating life-threatening or very serious conditions that are rare and affect less than five of every 10,000 persons in the EU. An orphan drug designation provides 10 years of potential market exclusivity, assistance in preparing the marketing application and assistance for clinical development.
“We are pleased to make continued progress in our Amphotericin B Inhalation Powder (ABIP) program and look forward to using the scientific guidance and assistance available through the EMEA’s Orphan Medicinal Drug Program,” said David Johnston, Nektar senior vice president of research and development.
ABIP is under development for the prevention of pulmonary fungal infections such as aspergillosis in high-risk immunosuppressed patients. Immunosuppressed patients are vulnerable to opportunistic fungal infections, such as aspergillosis, which start in the lungs and spread throughout the body.