An Aberdeen firm has achieved a key milestone in the US.
NovaBiotics, based at Craibstone in Aberdeen, said yesterday its Lynovex therapy for cystic fibrosis (CF) sufferers had been given fast-track designation status by America’s Food and Drink Administration (FDA).
It means the drug, which has been developed for the treatment of CF-associated lung disease, can pass through the US review process quicker.
The therapy is in a global second phase clinical trial. Lynovex breaks down the thick, sticky mucus produced by the lining of the airways in CF patients, and kills the bacteria that thrive in this environment.
NovaBiotics chief executive Deborah O’Neil said: “Gaining FDA fast-track designation for oral Lynovex marks a very significant milestone in the development of this important drug and is recognition of its novelty and its potential clinical impact in CF.
“Lynovex in oral form is unique as the only therapy specifically designed to tackle exacerbations, despite these events being the main driver of pathology and decline in lung function over time in CF patients.”