FDA Panel: Tolerating Approval Outliers Would Set ‘Dangerous Precedent’
An unprecedented wait for final FDA approval will drag on for two orphan lymphoma drugs, at least a little while longer, as the agency decides how to end the delays and prevent them from happening again. The dihydrofolate reductase inhibitor pralatrexate (Folotyn) received accelerated approval in 2009 and the histone deacetylase (HDAC) inhibitor belinostat (Beleodaq) […]
Do Orphan Drugs Really Need Development Incentives?
Drugs approved for an “orphan” indication ended up making just as much money as their non-orphan counterparts, even though they were helped by incentives during development, researchers found. There was no significant difference in median 5-year net sales between orphan and non-orphan drugs ($719 million vs $812 million, P=0.09), reported Benjamin Rome, MD, MPH, of […]