Orfadin, a drug used to treat a condition causing kidney and liver damage, has now received the FDA’s go-ahead for once-a-day use, cutting its dosing frequency in half.
Hereditary tyrosinaemia Type 1, the main target of the Swedish drug Orfadin, can also cause neurological damage in the approximately 1,000 people it affects worldwide.
Orfadin is manufactured by Swedish Orpha Biovitrum AB, and is cleared for use in patients above age 5 who suffer from the uncommon disorder. Earlier this year, the European Commission approved the same dosing schedule.
“Orfadin is the first nitisinone product approved for once-daily use in the U.S.” said Milan Zdravkovic, the company’s senior vice president and chief medical officer, in a press release. “It follows Sobi’s introduction of Orfadin 20 mg capsules and Orfadin oral suspension.”
The medication treats HT-1 in concert with with dietary restrictions by reducing the presence of certain toxins that accumulate in the body when the tyrosine amino acid is processed incorrectly, the release explained.
SOBI, the manufacturer is a $600 million firm based in Stockholm.
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