FDA Grants Orphan Drug Status to Inhaled Imatinib Formulation

FDA Grants Orphan Drug Status to Inhaled Imatinib Formulation

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FDA Grants Orphan Drug Status to Inhaled Imatinib Formulation

AER-901, an inhaled formulation of imatinib being developed as a treatment for pulmonary arterial hypertension (PAH), has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA). The investigational therapy was designed with the goal of reducing the side effects reported among PAH patients using an approved oral formulation of imatinib. The orphan drug designation, given to the therapy’s developer, Aerami Therapeutics, supports investigative treatments for rare diseases — those that affect…

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