Could Opportunity for Takeda's Subcutaneous Entyvio Diminish by the Time It Reaches Its Now Projected 2023 US Approval? Spherix Investigates

EXTON, Pa., Dec. 9, 2021 /PRNewswire/ -- In their most recent earnings call on October 29, 2021, Takeda revealed that discussions with the FDA have led to a potential approval for subcutaneous (SC) Entyvio in 2023, at the earliest. Prior reports stated there was a possibility for an approval in 2022, and in the topsy-turvy inflammatory bowel disease (IBD) market, this type of delay can have significant financial ramifications for a franchise.

In the case of Takeda, the postponement of a potential FDA approval could leave a large amount of revenue on the table. Indeed, the intravenous (IV) formulation of Entyvio has emerged as a force to be reckoned with in the US ulcerative colitis (UC) and Crohn's disease (CD) markets. Their positive experience with Entyvio IV has led US gastroenterologists to look forward to the SC version of the anti-integrin agent.

In the latest reports included in Spherix's RealTime Dynamix™ services offered in both UC and CD, each collecting the responses of 102 US gastroenterologists, respondents reported very favorable brand share for Entyvio IV. In fact, Takeda's brand outpaces AbbVie's Humira and Janssen's Remicade as the share leader in UC for the first time in over a year.

While Entyvio IV falls behind the long-tenured TNF inhibitors in terms of share in CD, the Takeda brand holds an unmoved position behind Humira and Remicade as they continue to dwindle. Of note, however, is that Janssen's Stelara seems to be picking up the slack in more recent quarters and is projected to continue doing so.

How does this translate to excitement and receptivity around Entyvio SC? Nearly one in five surveyed gastroenterologists volunteer "Entyvio SC" when asked (unaided) if they are aware of any UC or CD therapies in development – more than what is reported for any other agent or even entire class/mechanism of action. The same holds true for actual familiarity with Takeda's drug versus other pipeline agents.

So, not only are physicians well informed about Entyvio SC, but the majority of respondents in the Q4 survey selected the drug as their most preferred agent in development for both UC and CD (far exceeding other "hot" pipeline assets such as AbbVie's Skyrizi and Rinvoq). Nearly nine in ten US gastroenterologists also believe the SC extension will play a leading/definite role in the future management of IBD patients.

Since Entyvio SC's mid-2020 EU approval, the brand has captured a significant portion of the EU5 UC and CD markets, according to ongoing research included in the parallel EU RealTime Dynamix™ services. While much of that prescribing has been cannibalization of the IV formulation, Entyvio IV prescribing has only decreased slightly across the EU5. In fact, Entyvio's combined IV and SC share is four percentage points higher in UC and five points higher in CD than Entyvio's share when it was just the IV formulation.

The absence of Entyvio SC from the US market is especially felt by IBD physicians and patients, as several market events have curbed the opportunity for other therapies to emerge as a force in either the UC or CD treatment areas. If Entyvio SC were available in the US, they might have been able to capitalize on the following events:

• Etrolizumab's Phase 3 failure in ulcerative colitis in 2020
• The decision earlier this year for filgotinib to not apply for approval in UC in the US
• The relatively slow uptake for Zeposia so far in ulcerative colitis
• The recently updated label from the FDA for current and potential JAKs in IBD – Pfizer's Xeljanz and Rinvoq
• The absence of intense, price-based competition that may come in 2023 with arrival of a Humira biosimilar

Each of these events represents a missed opportunity with the absence of Entyvio SC from the US market, and it will likely build as more pipeline therapies are introduced and prescribing continues to pick up for new and emerging brands. Spherix will continue to monitor gastroenterologists' awareness and anticipation of an Entyvio SC formulation as well as the impact of other market events on overall prescribing behavior in UC and CD.

About RealTime Dynamix™

RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.

Learn more about our services here.

About Spherix Global Insights

Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

All company, brand or product names in this document are trademarks of their respective holders.

For more information contact:

Eric John, Gastroenterology Franchise Head

Email: info@spherixglobalinsights.com

www.spherixglobalinsights.com

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