Breakthrough therapy designation is a fast drug mechanism which is good news for the Rett community. It's also potentially good news for people suffering from all types of neurodevelopmental and neurodegenerative conditions.
The simple explanation is the prevalent prescribing for off-label drug use.
According to one source, more than one in five outpatient prescriptions written in the US are for off-label therapies. The FDA regulates drug approval but doctors prescribe drug use.
Consider the case say in Alzheimers Disease where there are no other therapies and a new neuroprotective drug comes onto the market which is designated as safe and well tolerated. Say that the drug targets pathologies which are primary features of many acute and chronic CNS conditions.
The clock is ticking.
Breakthrough therapy designation is a fast drug mechanism which...
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