FDA changes its mind and approves Takeda’s Eohilia

In its second attempt, Takeda has secured FDA approval for Eohilia, which becomes the first and only oral therapy in the US for eosinophilic oesophagitis (EoE).

The US regulator has cleared Eohilia (formerly TAK-721), an oral suspension formulation of the well-established steroid drug budesonide, for people 11 years and older with EoE after turning down Takeda’s first attempt in 2021 with a request for an additional clinical trial.

Takeda had hoped that Eohilia would be the first-ever treatment for EoE, but that crown was snatched by Sanofi and Regeneron’s injectable antibody Dupixent (dupilumab), which was approved for the condition in 2022.

Faced with the cost of a second trial, the Japanese drugmaker said after the first rejection it was planning to abandon the whole programme, but changed its mind amid calls from patients and physicians to deliver a much-needed additional treatment option and a reanalysis of data from its existing clinical trials.

A decision was also taken to reduce the duration of Eohilia treatment to a fixed 12-week course in the second filing, rather than positioning the drug as an ongoing maintenance treatment.

EoE is a chronic condition in which the oesophagus becomes inflamed as a result of an inflammatory reaction, generally caused by an allergy, and affects around 1 in 2,000 people in the US. It can cause the oesophagus to narrow, making swallowing difficult, which can affect appetite. It can also lead to other symptoms like discomfort and vomiting.

Eohilia is specifically designed to coat the oesophagus, localising the anti-inflammatory activity of budesonide and minimising systemic absorption, which can lead to side effects.

“Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options,” commented Ikuo Hirano, an oesophageal disease specialist at Northwestern University Feinberg School of Medicine.

“With Eohilia, it’s gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address oesophageal inflammation and EoE dysphagia symptoms,” he added.

Eohilia is given over a 12-week course in single-dose 2 mg/10 ml stick packs, taken twice daily, and is due to be launched towards the end of this month with a list price of $1,875 per month. Dupixent costs around $3,800 for two prefilled pens, which are taken either once a week or once every other week for EoE, so Takeda’s drug does present a lower-cost alternative.

Takeda acquired the drug as part of its $62 billion merger with Shire in 2019, and it was one of around a dozen pipeline drugs – collectively known as Wave1 – for which the company had blockbuster aspirations. It now seems to have scaled back its hopes for Eohilia to $500 million or less.

The drugmaker has had mixed results from Wave1, with approvals for dengue fever vaccine Qdenga and post-transplant cytomegalovirus (CMV) therapy Livtencity (maribavir), while first-in-class lung cancer therapy Exkivity (mobocertinib) reached the market only to be withdrawn from sale and pevonedistat failed to show efficacy in myelodysplastic syndromes and acute myeloid leukaemia (AML).

It has chalked up a series of other FDA approvals in the last few months, however, including congenital thrombotic thrombocytopenic purpura (cTTP) therapy Adzynma (ADAMTS13, recombinant) and immune globulin-based products Hyqvia and Gammagard Liquid for chronic inflammatory demyelinating polyneuropathy (CIDP).