Takeda Pharmaceutical Company has announced that it has received a Complete Response Letter from the United States Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for TAK-721 for the treatment of eosinophilic oesophagitis (EoE).

TAK-721 is a budesonide oral suspension that was granted priority review by the FDA in December 2020. You can read more about the drug here.

What this means for EoE patients

With no EoE treatment currently approved for use in the USA, this is a disappointing setback as patients will be forced to continue with off-label medications designed for treating asthma.

Currently, budesonide nebuliser Asthma treatment is sometimes prescribed for EoE patients. Instead of inhaling the treatment patients are required to open the small budesonide repsules and mix them into a slurry mixture, often with syrup or with various homemade ingredients such as Splenda or apple sauce in order for it to be thick enough to coat the oesophagus when swallowed.

This can be difficult for patients to obtain and also a challenge for patients to administer correctly.

Around the globe, various pharmaceutical companies are developing this and other treatments for EoE including an orodispersible budesonide tablet (Jorveza) that has received approval and recommendation in Europe and Canada.

We will continue to monitor and keep you informed of further updates from Takeda, and any other treatments for EoE.