U.S FDA Grants Orphan Drug Designation for AER-901 (Inhaled Imatinib)

Release Date: 19-Sep-2021

US FDA has designated Orphan Drug designation to AER-901 (inhaled imatinib) for the treatment of pulmonary arterial hypertension. Imatinib is currently available as an oral formulation to treat several types of cancers. AER-901 is an investigational drug-device combination therapy that contains a nebulized formulation of imatinib, a tyrosine kinase inhibitor, and the Foxandreg; device, a breath-actuated smart nebulizer. AER-901 is likely to increase drug uptake and dosing consistency by delivering imatinib directly into the lungs and small airways while avoiding key adverse events associated with oral imatinib.

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