Dipharma's Disanit (Nitisinone capsules 2, 5 and 10mg) is now under marketing authorisation (MA) evaluation in the EU.
Tyrosinemia is a genetic disorder characterized by disruptions in the multistep process that breaks down the amino acid tyrosine
Disanit is the first stable capsule formulation of Nitisinone for the treatment of hereditary Tyrosinemia type-1 (HT-1). The Swiss company has also announced plans to file an Abbreviated New Drug Application (ANDA) with the US FDA.
Disanit is the improved generic version of SOBI's Orfadin, indicated for the treatment of HT-1, a very rare inborn error of metabolism (IEM). Disanit is a stablecapsule formulation that can be stored at room temperature without the need of refrigeration.
Disanit is the third product of Dipharma undergoing a regulatory marketing authorisation procedure.
Diterin (sapropterin dihydrochloride 100mg tabs) has already been approved in South Korea and Russia for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU).
Miglustat was submitted in the USA through an ANDA in 2016 for the treatment of Gaucher disease. Dipharma also confirms ongoing development of several other products for the treatment of rare metabolic diseases.
Disanit will be the first capsule formulation of Nitisinone in Europe that can be stored at room temperature.
“Once approved, Disanit will be the first capsule formulation of Nitisinone in Europe that can be stored at room temperature, simplifying distribution, decreasing cold-chain related wastage and finally improving ease of use for patients,” commented Marc-Olivier Geinoz, CEO of Dipharma.
The company also announces that international patent applications were filed claiming a stable crystalline form of Nitisinone, stable capsule formulations of Nitisinone and the proprietary technologydeveloped to improve the product stability, without modifying the pharmaceutical form the patients are familiar with.
Dipharma is currently working with its partners to make Disanit and all the rest of its product portfolio available worldwide.