FDA Approves Multiple Ulcerative Colitis Agents, Bringing New Drugs, Routes of Administration to Class

The ulcerative colitis (UC) space has seen multiple new approvals recently that could focus payer management even more on the condition. Payers already take an aggressive approach toward managing branded agents within the class, according to a Zitter Insights survey.

While no cure exists for the inflammatory bowel disease, the FDA has approved numerous agents to treat signs and symptoms of the condition. In addition to the nine biosimilars of AbbVie Inc.’s Humira (adalimumab) that have launched in the U.S. in 2023, a handful of other therapies have been approved by the agency since late September. All of the agents offer maintenance dosing either through an oral or subcutaneous route of administration.

On Sept. 27, the FDA approved a subcutaneous formulation of Takeda Pharmaceuticals U.S.A., Inc.’s Entyvio (vedolizumab) for the maintenance treatment of adults with moderately to severely active UC. The agency initially approved the integrin receptor antagonist on May 20, 2014, as an intravenous infusion, which remains available. Dosing for the drug starts with infusions, and then people can switch to subcutaneous injections.

On Oct. 13, the FDA approved Pfizer Inc.’s Velsipity (etrasimod) for the treatment of adults with moderately to severely active UC. The tablet is the second sphingosine 1-phosphate (S1P) receptor modulator approved for UC following Bristol Myers Squibb’s Zeposia (ozanimod), approved May 27, 2021.

On Oct. 23, the FDA approved Celltrion USA’s subcutaneous Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active UC and Crohn’s disease following treatment with an intravenously administered infliximab product. The tumor necrosis factor (TNF) inhibitor is the first FDA-approved subcutaneous formulation of infliximab; it also is available as an intravenous infusion under the name Inflectra. The latter drug was initially approved April 5, 2016, as the first biosimilar of the Janssen Pharmaceutical Companies of Johnson & Johnson’s Remicade (infliximab), but the FDA approved Zymfentra as a novel drug.

On Oct. 26, the FDA approved Eli Lilly and Co.’s Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active UC in adults. The agent is the first interleukin-23p19 (IL-23p19) antagonist for this indication. It is approved both as an intravenous infusion and a subcutaneous injection. Dosing starts with infusions and then shifts to injections.

Then on Oct. 31, the FDA approved Amgen Inc.’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson for the treatment of adults with moderately to severely active Crohn’s disease and moderately to severely active UC and the treatment of people at least 6 years old with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis. The human IL-12/-23 antagonist is approved for all of Stelara’s indications and for both intravenous and subcutaneous administration.

For the Managed Care Biologics & Injectables Index: Q3 2023, from Aug. 13, 2023, to Sept. 29, 2023, Zitter Insights polled 35 commercial payers covering 117.5 million lives, 27 Medicare payers representing 43.6 million lives and 53 gastroenterologists about their management and prescribing of UC therapies. More than half of payers said that managing branded UC drugs is a high priority for them and that they take an aggressive approach to management of the agents (see chart).

Both AIS Health and Zitter Insights are divisions of MMIT.

Payers with 55% of commercial lives, the same amount of Medicare beneficiaries and 49% of gastroenterologists expressed average satisfaction with current UC medications. Payers with 91% of commercial lives, 98% of Medicare lives and 75% of gastroenterologists said there was either moderate or high unmet need in the treatment of UC. More than half of both payers and gastroenterologists said that there is a high disease burden for people with UC.

For more information on the Zitter Insights data, contact Jill Brown Kettler at jkettler@mmitnetwork.com.


© 2024 MMIT
Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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