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FDA rejects Takeda’s Eohilia after delays

After more than a year on ‘priority review’, the FDA has said it cannot approve Takeda’s budesonide oral suspension without a further clinical study

FDA building

Takeda has received a Complete Response Letter from the US Food and Drug Administration (FDA) saying it cannot approve its oral suspension of the corticosteroid budesonide for the treatment of eosinophilic oesophagitis (EoE).

Eosinophilic oesophagitis is a rare, chronic inflammatory disease of the oesophagus that is known to affect about 1 in 2,000 people in the US and is growing in prevalence. The chronic inflammation seen with EoE can lead to a range of symptoms including difficulty swallowing, vomiting and heartburn.

It is believed to involve a complex interplay of genetics, environmental factors and immune system dysfunction and, in severe cases, can lead to narrowing of the oesophagus causing food to become stuck.

Treatment with corticosteroids is common. ‘Orodispersible’ tablets, which dissolve inside the mouth as saliva is swallowed contain budesonide and are available in Europe under the brand name Jorveza.

However, Takeda hoped that an oral suspension of the drug – designed specifically to treat the localised inflammation caused by EoE – would become the first FDA-approved treatment for the chronic condition. The company even announced its intended brand name for the treatment, Eohilia, yet these hopes now appeared to have been dashed by the FDA.

“We are disappointed by the outcome of the FDA’s review of TAK-721, and that EoE patients will still be without a treatment option that the FDA has approved as safe and effective,” said Ramona Sequeira, head of Takeda’s US business unit. “Takeda is assessing the details of the CRL and evaluating a regulatory path forward.”

The rejection by the FDA potentially clears the way for Sanofi’s Dupixent (dupilumab), which received breakthrough therapy designation in EoE back in September 2020.

In October 2021, Sanofi announced results of a second phase 3 trial for Dupixent in EoE that showed improvements in swallowing and reduced inflammation. Dupixent is a monoclonal antibody that is believed to target the cause of the inflammation seen in EoE.

Dupixent is already approved in the US, Europe, Japan and other countries for specific patient populations with atopic dermatitis and asthma. More than 300,000 patients have been treated globally.

Article by
Hugh Gosling

23rd December 2021

From: Regulatory



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