FDA denies approval of TAK-721 (budesonide oral suspension) for EoE
Takeda, the pharmaceutical company developing TAK-721 (budesonide oral suspension) for the treatment of EoE, announced that the U.S. Food and Drug Administration (FDA) responded to the TAK-721 New Drug Application, indicating the drug cannot be approved in its present form.
Takeda reports that the FDA recommended an additional clinical study to help resolve their feedback.
“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, President, U.S. Business Unit and Global Portfolio Commercialization, Takeda, in a press release issued by the company. “Takeda is assessing the details of the CRL and evaluating a regulatory path forward.”
Lirentelimab met histologic co-primary endpoints but missed symptomatic co-primary endpoints in both ENIGMA and KRYPTOS studies
Allakos Inc., a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, reported Phase 3 data from ENIGMA 2 (a study of lirentelimab in patients with eosinophilic gastritis and/or eosinophilic duodenitis) and Phase 2/3 data from KRYPTOS (a study of lirentelimab in patients with eosinophilic esophagitis.
Both studies met their histologic endpoints, but did not achieve statistical significance on the patient reported symptoms endpoints.
In a company press release, Dr. Craig Paterson, MD, Chief Medical Officer of Allakos states, “Although the EGID results are surprising and disappointing, we will continue to analyze the data to understand the results and to determine the path forward for lirentelimab in EGIDs.”
Tezspire approved for severe asthma in ages 12+
Tezspire (tezepelumab) has been approved in the U.S. for people aged 12 years and older with severe asthma. Tezspire is the first biologic approved for severe asthma without phenotype (e.g., eosinophilic or allergic) or biomarker limitations. This therapy is also in development for other potential indications, including eosinophilic esophagitis. Learn more.