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US FDA postponed Takeda Eohilia's review of Takeda's "turning year" and faces challenges!

 Last Update: 2021-08-04
 Source: Internet
 Author: User

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CompilationTom Lee

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.

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.

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

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

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.

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
.

In terms of specific data, Takeda Pharmaceutical's full-year reported revenue for fiscal year 2020 was 3197.

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

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