The Saudi Food and Drug Administration (SFDA) has approved Swedish Orphan Biovitrum’s (Sobi) Orfadin (nitisinone) capsules in all strengths (2 mg, 5 mg, 10 mg and 20 mg) for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
HT-1 is a progressive, rare genetic disease that may result in liver and kidney complications and in most cases fatal if untreated. In the most common form of the disease, symptoms arise within the first six months of the child’s life.
“The Kingdom of Saudi Arabia is the largest market in the Middle East, and our focus will now be to ensure timely and sustainable access to treatment for people living with HT-1 on this market”, says Ahmad Abu-Dahab, Regional Director Middle East & Turkey.