An Inflammatory disease that can affect many organs, but mainly affects lungs.
The inflamed cells are called granulomas.
It affects every race and ethnicity, but more common in African Americans.
Believed to be caused by: Dust, mold, mycobacteria, occupational exposure, and genetic predisposition.
In addition to lungs, it can affect the following areas: Ocular - Neurologic - Cardiac - Skin - Liver
It is considered an Orphan disease
WHAT IS AN ORPHAN DRUG?
WHAT IS AN ORPHAN DRUG?
WHAT IS AN ORPHAN DRUG?
A Drug that is Intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 people in US.
FDA will give higher priority for Approval
FDA will grant 7 years protection exclusivity post-approval
Allowance for Higher Treatment Costs
Granting up to $2.5 million to be spent on clinical trials.
Waiver of Prescription Drug User Fee Act (PDUFA) fees, a value of approximately $2.9 million in 2021
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