Advanced Inhalation Therapies Ltd (AIT), an anti-microbial therapeutic company, recently announced that the European Commission, acting on recommendations from the Committee for Orphan Medicinal Products of the European Medicines Agency, has granted orphan medicinal product designation to the firm’s proprietary high dose formulation of nitric oxide (NO), AIT-CF, to address the treatment of patients with cystic fibrosis.
AIT has ended a Phase 2a trial for AIT-CF testing it as a treatment for cystic fibrosis adult patients. In February 2015, the Company announced that the United States Food and Drug Administration (FDA) granted an Orphan Drug Designation to AIT-CF for adjunctive treatment of cystic fibrosis. Now, the European Commission has followed suit, further supporting the drug’s promising therapeutic benefits.
David Greenberg, the Chief Medical Officer of Advanced Inhalation Therapies, commented in a press release: “AIT-CF potentially affords a significant benefit to CF patients. As a naturally occurring chemical in the body, NO, when inhaled at high concentrations, kills bacteria and fungi in the lungs of CF patients and has shown broad anti-infective activity. The European Orphan Drug Designation for AIT-CF affords additional benefits as we continue to advance its clinical development.”
The European Commission’s Orphan Designation is a status assigned to a drug or medicine that treats a rare condition. A rare condition in the European Union (EU) corresponds to a disease that affects less than 5 in 10,000 people. Cystic fibrosis affects about 0.8 in 10,000 people in the EU.
If an EMA Orphan Medicinal Product Designation is awarded, pharmaceutical companies have the opportunity to benefit from incentives that the EU offers to accelerate development of a product that helps treat, prevent or diagnose a life-threatening or chronic rare disease. An additional 10-year period of exclusive marketing in the EU after product approval is also granted. The Orphan Medicinal Product Designation provides access for firms seeking protocol assistance from the EMA during the development phase of the product and also assures direct access to a centralized marketing authorization route.
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