The US Food and Drug administration has issued a letter of support to FLUIDDA after examination of study results where Functional Respiratory Imaging was used to assess bio-equivalence between a generic and a reference drug. Manufacturers of generic drugs are required to demonstrate that their drugs are therapeutically equivalent to the reference drug before they can enter the market. In the field of respiratory medicine demonstrating equivalence is particularly challenging since often the drug is not given as a tablet but through an inhaler. As the drug reaches the sick lung before the bloodstream, relying only on drug concentrations in the blood (as is often the way to assess equivalence) also becomes problematic. These elements make respiratory generic drugs so-called complex generics.
The FDA recognizes the importance of high quality generic drugs to keep drugs affordable without jeopardizing the patient’s health. The conventional way of developing generic drugs uses the classical lung function tests (eg Forced Expiratory Volume in one Second, FEV1) which have limited sensitivity. As a result, traditional clinical bio-equivalence trials require a large number of patients which makes them expensive, thereby defying the point of lower cost drugs as the R&D expense drives drug prices.
The FDA recognizes the potential of FRI to provide better insights into the efficacy of a test drug compared to a reference drug in a small patient population. Using FRI in bio-equivalence trials therefore provides an opportunity to ensure that the generic drug acts in the same way as the original drug and this through smaller, shorter and cheaper clinical trials.
Dr. Jan De Backer, FLUIDDA’s CEO, states: “We are delighted with this new letter of support by the FDA as it highlights another application of our technology. We have previously demonstrated the potential of our FRI technology to develop innovator drugs for lung diseases such as Lung Fibrosis, asthma and COPD. Now we also demonstrated the potential in the space of bio-equivalence trials. FLUIDDA is committed to help bring effective, safe and affordable to the patients and having the FDA’s support is of tremendous value.”
The full letter can be found here.