FDA Delays Review of Takeda's Eohilia, Casting Shadow Over Company's 'Pivotal Year'

Compiled & Translated | Tom Li

Takeda CEO Christophe Weber has consistently referred to 2021 as the company's "turning point year," as Takeda aims to advance the development of its late-stage pipeline and launch several new drugs this year. However, as it currently stands, at least one drug is unlikely to achieve this target.

During a conference call with investors on Friday, Takeda’s head of research and development, Andy Plump, stated that the FDA did not approve Eohilia by the PDUFA date. Eohilia is an oral suspension of the corticosteroid budesonide. Takeda noted that if approved, Eohilia would become the first FDA-approved treatment for eosinophilic esophagitis, an inflammatory disease affecting the esophagus.

However, Eohilia does not appear to be an asset poised for substantial profitability. According to Evaluate Pharma's data from March this year, the drug's projected sales for 2026 stand at just $357 million. Plump explained that the FDA missing the PDUFA date for Eohilia's approval is a rather "significant event," as the agency is obligated to make every effort to honor PDUFA agreements. Takeda's Eohilia application (designated TAK-721) was granted Priority Review by the FDA in late 2020. The company disclosed in April this year that the approval process had been delayed, and today, four months later, Plump stated that Takeda still has no clarity on what the "target approval date" for Eohilia will be. Plump noted that Takeda remains in discussions with the FDA, implying that the company has received a "request for additional information," but provided no further specifics regarding the FDA's missed decision date.

The FDA recently delayed decisions on several drug applications, primarily citing COVID-19 pandemic-related travel restrictions that have prevented pre-approval manufacturing inspections. However, in many cases, the agency has simply rejected the applications or postponed PDUFA dates without providing explicit reasons, as was the case with Novartis's cholesterol drug inclisiran. Nevertheless, any approval delay for Eohilia would be positive news for Sanofi's blockbuster Dupixent. This biologic, which has received FDA Breakthrough Therapy designation, is preparing to submit a regulatory application next year for the treatment of eosinophilic esophagitis.

Notably, Eohilia is not the only drug asset for which Takeda is seeking an extension of the regulatory review period. Recently, the European Medicines Agency (EMA) converted the previous accelerated assessment of Takeda’s dengue vaccine, TAK-003, to a standard evaluation. Consequently, the review decision, previously expected by the end of March 2022, has been delayed, and the company now anticipates that European regulators will reach a decision later next year. Eohilia and TAK-003 are among more than a dozen new drugs Takeda aims to launch in fiscal year 2024. This year, the company also expects to receive an FDA decision on maribavir for the treatment of post-transplant cytomegalovirus (CMV) infection refractory to prior therapy, as well as regulatory feedback on mobocertinib for non-small cell lung cancer (NSCLC) harboring exon 20 insertion mutations. This drug represents a potential competitor to Johnson & Johnson’s Rybrevant.

Takeda hopes that new drugs and recently approved medications will drive the company's sales growth in the coming years. Sales of Takhzyro, a treatment for hereditary angioedema, slowed this quarter, reaching ¥25.5 billion ($229 million). On a constant currency basis, growth was only 6%. Starting this year, subcutaneous Takhzyro has also begun facing competition from BioCryst Pharmaceuticals' oral drug Orladeyo. However, Ramona Sequeira, President of Takeda's U.S. Business Unit and Global Portfolio Commercialization, remains optimistic about the drug. During a conference call on Friday, she noted that with Takeda's current fiscal year ending in March of next year, Takhzyro is still on track to achieve a sales growth target of approximately 20%, driven by geographic expansion and continued market penetration in the United States.

Weber previously stated that 2021 marks a pivotal turning point for Takeda, as the company plans to increase R&D investment and drive pipeline transformation. Takeda is confident of reaching 5 trillion yen (approximately $47 billion) in revenue by fiscal year 2030. According to specific data, for fiscal year 2020, Takeda Pharmaceutical Company Limited reported full-year revenue of 3,197.8 billion yen (approximately $28.9 billion), representing a year-on-year decline of 2.8%. In the first quarter of fiscal year 2021, Takeda's revenue reached 816.6 billion yen ($74.4 billion). On a constant currency basis, the company's first-quarter performance increased by 3.8% year-on-year.

Source: The curious case of Eohilia: Takeda drug hit with mysterious FDA delay as company leans on launches for growth