Ravicti® (glycerol phenylbutyrate) approved in Saudi Arabia, Qatar and Kuwait

Stockholm, August 18, 2025 Immedica is pleased to announce that Ravicti® (glycerol phenylbutyrate) has received regulatory approval in Saudi Arabia, Qatar, and Kuwait. This marks a significant milestone in our mission to bring new treatments for rare diseases to patients across the MENA region.

"We are pleased to expand the availability of Ravicti to patients in these three regions," said Anders Edvell, CEO of Immedica. "This approval underscores our commitment to advancing rare disease care and ensuring that patients have access to the treatments they need."

"Ashraf Attia, General Manager MENA, added, "This approval is a significant step forward in our mission to provide treatments for rare diseases in the MENA region. We are grateful for the support of the health authorities and look forward to continuing our work to improve patient outcomes."

About Urea Cycle Disorders (UCD)
Urea cycle disorders are a group of metabolic diseases that affect a specific enzyme or transporter in the urea cycle leading to elevated ammonia or glutamine levels in the circulation. Symptoms of the disorder can begin at any age, where more severe defects are seen with an onset of the disease  early in life. UCD patients may experience episodes, called hyperammonemic crises, when ammonia levels in the blood become excessively high, which can result in irreversible brain damage, coma, or death. Beyond hyperammonemic crises there are also more subtle symptoms including vomiting, refusal to feed, irritability, muscular hypotonia as well as delayed motor and psychointellectual development. As a group, these disorders occur in 1 in 35,000 newborns.

About Ravicti® (glycerol phenylbutyrate)
Ravicti is a medicine used to treat patients of all ages with UCDs, including deficiencies of carbamoyl phosphate synthetase I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

The medicine is used to reduce the amount of ammonia in the blood in order to reduce the risk of neurological consequences.

About Immedica
Immedica is a pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and specialty care products. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, regulatory, medical affairs and market access, as well as a global distribution network serving patients in more than 50 countries. Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need. Immedica’s therapeutic areas are within RARE metabolic, RARE hematology & oncology, RARE neurology and specialty care. Immedica was founded in 2018 and employs today around 130 people across Europe, the Middle East and the United States. Immedica is backed by the investment firms KKR and Impilo.

For more information visit www.immedica.com.

Immedica contact:
Linda Holmström
Head of Communication
[email protected]
+ 46 708 73 40 95