Immedica Pharma has announced that RAVICTI has been accepted and granted Priority Review for the New Drug Application (NDA) in China.
In April, another submission for RAVICTI Market Authorisation Approval was accepted by the Department of Health (DoH) in HongKong.
“With these submissions in China and HongKong, Immedica continues to rapidly bring Ravicti to patients globally. We remain confident in Ravicti’s potential to change the current management of Urea Cycle Disorders in this part of the world,” says Anders Edvell, CEO of Immedica.
Chronic management of patients with UCDs
The proposed indication for glycerol phenylbutyrate in China is the chronic management of patients with UCDs that cannot be managed with protein restriction and/or amino acid supplementation alone. Urea cycle disorders (UCDs) are rare inherited metabolic disorders characterized by hyperammonemia that arise in either the neonatal period or later. The clinical manifestations include changes in the level of consciousness similar to encephalitis or drug intoxication, acute encephalopathy, epilepsy, lethargy, and mental disorders. Hyperammonemia may lead to severe neurocognitive impairment, coma, and even death.
Winhealth Pharma’s 2020 agreement with Immedica
In December 2020, Winhealth Pharma signed an agreement with Immedica Pharma AB, under which Winhealth Pharma was granted exclusive commercialization rights for glycerol phenylbutyrate in Greater China, South Korea, Singapore, Vietnam, Indonesia, Malaysia, the Philippines and Thailand.