The disease that affects at least 7,400 people in Russia, according to the Russian Cystic Fibrosis Registry.
Bronchitol will be manufactured and exported to Russia from our purpose‐built factory in Sydney.
It will be used to treat children aged 6 and above and adults throughout Russia who are suffering from the debilitating symptoms of cystic fibrosis,” said Gary Phillips, Pharmaxis CEO, in a press release.
Bronchitol was designated an orphan drug by regulators in February, and its approval in that country opens it to patients age 6 or older.
“This is an important milestone for the company and a noteworthy achievement for Australian innovation.
Bronchitol works by rehydrating the airways or lung surface, and promoting a productive cough.
Clinical trials have shown that Bronchitol helps to increase mucus clearance, and improve the lung function and the quality of life of people with CF.It does not provide medical advice, diagnosis or treatment.This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment.“I am also proud of the work we have done in having Bronchitol become the first drug to be granted marketing approval under the new Russian legislation.We were instrumental in demonstrating the need for the new legislation and this will ultimately mean better access to a range of medicines for Russian patients in need.” Russia’s Ministry of Health Orphan Committee will now review Bronchitol’s application for reimbursement under its Seven Nosologies Program, which supports patient access to expensive medications for orphan — or rare — diseases such as CF.Because of the risks of patient-to-patient transmission of respiratory infection, CF patients must keep their distance from each other.