Takeda CEO Christophe Weber has always referred to 2021 as the company's "turning year". Takeda hopes to advance the development of later product lines and launch several new drugs this year. But at present, at least one drug is difficult to achieve this goal.

Takeda R&D director Andy Plump told investors during a conference call on Friday that the FDA did not approve Takeda Eohilia within the PDUFA date. Eohilia is an oral suspension of the corticosteroid budesonide. Takeda said that if the drug is approved, Eohilia will become the first drug approved by the FDA to treat eosinophilic esophagitis, an inflammation that affects the esophagus. Sexual disease.

However, Eohilia does not seem to be an asset that is expected to bring huge profits. According to the statistics of Evaluate Pharma in March this year, the estimated sales of the drug in 2026 are only 357 million U.S. dollars. Plump explained that the FDA’s missed approval date for Eohilia’s PDUFA is a “significant event” because the agency is obliged to do its best to meet the PDUFA agreement. Takeda's Eohilia application (code TAK-721) will receive priority review by the FDA at the end of 2020. The drugmaker revealed in April this year that the approval was delayed. Today, four months later, Plump said that Takeda still doesn't know what Eohilia's "target approval date is like." Plump said that Takeda is still in dialogue with the FDA, implying that the company has received a "request for more information," but Plump did not provide more specific details about the FDA's missed ruling date.

The FDA recently postponed its decision on several drug applications, mostly due to travel restrictions caused by the COVID-19 pandemic and the inability to conduct pre-approved manufacturing inspections. But in many cases, the agency simply rejected the application or postponed PDUFA without giving a clear reason, such as Novartis’s cholesterol drug inclisiran. However, any form of delay in Eohilia's approval is good news for Sanofi's blockbuster Dupixent. This biopharmaceutical approved by the FDA for breakthrough therapy is preparing to submit a regulatory application for the treatment of eosinophilic esophagitis next year.

It is worth noting that Eohilia is not the only drug asset in Takeda that is considering extending the review period. A few days ago, the European Medicines Agency has converted the previous accelerated review of Takeda dengue vaccine TAK-003 into a standard assessment. The results of the review will be delayed on the basis before the end of March 2022, and the company now expects European regulators to make a decision later next year. Eohilia and TAK-003 are one of a dozen new drugs that Takeda hopes to launch in fiscal year 2024. This year, the company also hopes to receive an approval response from the FDA regarding the use of maribavir for the treatment of cytomegalovirus infection after transplantation after the previous treatment, as well as the regulatory approval of mobocertinib for the treatment of non-small cell lung cancer with exon 20 mutations. The drug is a potential competitor of Johnson & Johnson's Rybrevant.

Takeda hopes that new drugs and recently approved drugs can drive the company's sales growth in the next few years. The hereditary angioedema drug Takhzyro slowed down this quarter, with sales reaching 25.5 billion yen ($229 million). Calculated at a constant exchange rate, it only increased by 6%. Beginning this year, the subcutaneous injection Takhzyro has also begun to face competition from BioCryst Pharmaceuticals' oral drug Orladeyo. But Ramona Sequeira, President of Takeda’s U.S. Business Unit and Global Portfolio Commercialization, is optimistic about the drug. He said on Friday’s conference call that Takeda’s current fiscal year will end in March next year due to geographic expansion and the US market. With continued penetration, Takhzyro can still achieve its sales growth target of about 20%.

Weber previously stated that 2021 is a key turning point for Takeda. Takeda will increase R&D investment and promote the transformation of production lines. Takeda is confident that it will reach 5 trillion yen (approximately US$47 billion) in revenue growth in fiscal 2030. From the specific data, Takeda Pharmaceutical's fiscal year 2020, the company's full-year reported revenue was 3197.8 billion yen (approximately 28.9 billion U.S. dollars), a year-on-year decrease of 2.8%. Takeda’s revenue in the first quarter of fiscal 2021 reached 816.6 billion yen ($7.44 billion). With the exchange rate unchanged, Takeda’s first-quarter performance increased by 3.8% year-on-year.