INN – Dornase alfa
Genetically engineered variant of the natural human enzyme that breaks down extracellular DNA.
Indications: symptomatic therapy in combination with standard therapy of cystic fibrosis in patients with the value of Forced Vital Capacity (FVC) at least 40% of the norm to improve lung function.
Dornase alpha is a basic mucolytic drug for the treatment of cystic fibrosis.
- Rapid and significant reduction of sputum viscosity
- Significant improvement in respiratory function
- Reducing the risk of upper respiratory infection
Generium is the first company in the world to develop and produce dornase alpha biosimilar.
- Comparison of biosimilar Tigerase and Pulmozyme in long-term symptomatic therapy of patients with cystic fibrosis and severe pulmonary impairment (subgroup analysis of a Phase III randomized open-label clinical trial (NCT04468100)). Authors: Elena L. Amelina,Stanislav A. Krasovsky,Nina E. Akhtyamova-Givirovskaya ,Nataliya Yu. Kashirskaya,Diana I. Abdulganieva,Irina K. Asherova,Ilya E. Zilber,Liliya S. Kozyreva,Lubov M. Kudelya,Natalya D. Ponomareva,Nataliya P. Revel-Muroz,Elena M. Reutskaya,Tatiana A. Stepanenko,Gulnara N. Seitova,Olga P. Ukhanova,Olga V. Magnitskaya,Dmitry A. Kudlay,Oksana A. Markova,Elena V. Gapchenko 2021 г.