Rare Daily Staff

Swedish Orphan Biovitrum said it has gained reimbursement in several EU member states for Ravicti, a new therapeutic option for the treatment of patients with urea cycle disorders, rare and life-threatening conditions.

Urea cycle disorders are the result of a severe dysfunction of the enzymes or transporters involved in the urea cycle that converts ammonia to urea. The condition results in an accumulation of toxic levels of ammonia in the blood and brain of patients. Elevated ammonia levels can cause coma and irreparable brain damage, potentially resulting in cognitive impairment, seizures, cerebral palsy, and death if untreated.

“There is a significant medical need for a more effective treatment of UCDs”, said Armin Reininger, Head of Medical & Scientific Affairs at Sobi. “We believe that the introduction of Ravicti offers a new option to manage ammonia levels and will contribute to further advancing the care of patients with UCDs.”

Sobi will initially lauch Ravicti in Sweden, Denmark, Austria, and Germany. The rollout in those countries will be followed by launches in the United Kingdom, Spain, and the Netherlands.

In Europe, Ravicti is indicated for chronic management of UCDs in adults and children from the age of two months, when the disease cannot be managed by dietary protein restriction and/or amino acid supplementation alone.

Sobi in December 2016 entered into a five-year distribution agreement with  Horizon Pharma for Ravicti in European countries, including United Kingdom, Germany, France, Italy and Spain. Under the agreement, Sobi will have exclusive marketing, sales, and distribution rights for the drug in the territory until the end of 2021. An ealier agreement between the two companies signed in 2013 covers Sobi’s distribution of Ravicti in the Middle East.

March 21, 2018
Photo: Armin Reininger, Head of Medical & Scientific Affairs at Sobi