Spherix Global Insights

May 04, 2023

Over Three Years After Receiving a Complete Response Letter From the FDA, Takeda’s Subcutaneous Formulation of Entyvio (Entyvio SC) is Poised to Enter a Rapidly Evolving UC Market, According to Spherix Global Insights

An FDA approval for Entyvio SC could exacerbate an already aggressive fight for second-line UC treatments.

Exton, PA., May 4, 2023 – In December 2019, Takeda Pharmaceutical Company (“Takeda”) announced the receipt of a complete response letter (CRL) for the subcutaneous (SC) formulation of its successful ulcerative colitis (UC) treatment, Entyvio (vedolizumab). The intravenous (IV) formulation of Entyvio is the only non-TNF UC therapy which enjoys a substantial share of advanced treated patients, and the highest share of any single brand.

Entyvio (IV) along with TNF inhibitors are, by far, the most often prescribed advanced therapies in the US for UC patients, comprising more than three-quarters of moderate to severe advanced therapy treated UC patients (2023 RealTime Dynamix™ US UC). With a virtual stranglehold on first-line, the two therapy classes have left the balance of alternative therapies – including Janssen’s Stelara (ustekinumab), AbbVie’s Rinvoq (upadacitinib), and BMS’ Zeposia (ozanimod) – in an aggressive battle to capture patients who have failed an initial round of biologic therapy.

In the race to capture second-line UC patients, Janssen’s Stelara (approved for UC in 2019) is currently favored by physicians. It will face increased pressure from Rinvoq, AbbVie’s potent JAK inhibitor, and the anticipated arrival of the IL-23 class, including Eli Lilly’s mirikizumab, AbbVie’s Skyrizi (risankizumab), and Janssen’s Tremfya (guselkumab).

To understand the threat posed by Entyvio SC, competitors can look to the European market, where the therapy has been available since May 2020. Trended analysis over five years shows the home administered version of Entyvio not only cannibalized a portion of its infused counterpart, but it also grew the combined Entyvio brand share (IV & SC) by a few percentage points (2022 Q4 RealTime Dynamix™ EU UC). The nominal advance occurred despite Stelara enjoying a favorable satisfaction rating vs Entyvio. Furthermore, data from Spherix’s lost opportunity analysis suggests Entyvio (both IV & SC) has improved its opportunity capture over the past four years (2022 RealWorld Dynamix™ IBD Switching EU). Whether it can repeat this achievement in the face of competition from IL-23s, JAKs, biosimilar TNFs and the likely entry of biosimilar ustekinumab in the coming year remains to be seen.

The dark horse in this race remains in Pfizer’s etrasimod which is set to launch in late 2023. While its class sibling Zeposia has struggled to find its footing in the UC market, the potential to offer biologic naïve patients a safe and effective oral therapy ahead of injections holds promise. Zeposia saw hints at gaining traction in first line share late 2022, but has since settled into later line option for physicians.

Spherix will be monitoring the potential Entyvio SC US launch and the evolving UC market through its RealTime Dynamix™ advisory service. Spherix’s Launch Dynamix™ service will maintain coverage of Rinvoq’s US launch in UC, and will initiate coverage of Eli Lilly’s mirikizumab once the FDA’s CRL issued in early April has been resolved.

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 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.

About Launch Dynamix™

Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.

About Spherix Global Insights

Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry. The company’s unique service offerings are powered by deep therapeutic knowledge, the Spherix Network specialty physician panel, and commercially relevant analyses to enable strategic decision-making by our valued customers.

A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology and ophthalmology.

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Spherix Global Insights Contacts

Geoff Red, Franchise Leader, Gastroenterology

[email protected]

Scott Upham, Corporate Communications

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