Can you name the year sapropterin was approved?

When was sapropterin approved by the FDA?

Sapropterin received FDA approval in December 2007. It treats phenylketonuria (PKU), a metabolic disorder that keeps the body from processing phenylalanine.

How does sapropterin work against PKU?

The drug activates phenylalanine hydroxylase, the enzyme missing or defective in PKU patients. This restores partial enzyme activity and reduces blood phenylalanine levels.

What conditions does sapropterin treat beyond the initial indication?

FDA granted sapropterin an additional indication in 2019 for patients who respond to the drug and who are on a phenylalanine-restricted diet.

When does the sapropterin patent expire?

The basic compound patent expired in 2014. Current exclusivity for the dihydrochloride salt form held by BioMarin ended around 2021.