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Home Takeda's Entyvio (Vedolizumab) IV Set to Become First Approved Therapy for Chronic Pouchitis in the EU

Takeda's Entyvio (Vedolizumab) IV Set to Become First Approved Therapy for Chronic Pouchitis in the EU

Dec 20, 2021 01:16 CST Updated 01:16
Takeda

Biopharmaceutical Manufacturer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.


Ulcerative Colitis (UC, Image Source: healthjade.com)

December 19, 2021 /BioValleyBIOON/ -- Takeda Pharmaceutical Company Limited recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval.Entyvio® (Generic name: vedolizumab), a gut-selective biologic administered as an intravenous (IV) injection, is indicated for the treatment of patients who have undergone proctocolectomy and ileal pouch-anal anastomosis (IPAA) due to ulcerative colitis (UC) and who are...AntibioticsInadequate Response or Loss of Response in Moderate to Severe Active Chronic PouchitisAdult patients.

Now, the CHMP opinion will be submitted to the European Commission (EC) for review, which typically makes a final decision within 2 months. If approved,Entyvio Will Become the First Drug in Europe to Treat Active Chronic Pouchitis. Currently, Entyvio has been approved in the European Union: for the treatment of patients who have had an inadequate response to conventional therapy orTumorModerate to Severe Cases with Inadequate Response, Loss of Response, or Intolerance to Tumor Necrosis Factor α (TNFα) AntagonistsUlcerative Colitis (UC) and Crohn's Disease (CD)Patient.

Patients with ulcerative colitis (UC) may require the removal of the colon and rectum (proctocolectomy) and the surgical creation of an ileal pouch to assist in stool retention (ileal pouch-anal anastomosis, IPAA). Pouchitis is a major complication for UC patients who have undergone proctocolectomy with IPAA, affecting approximately 50% of patients and potentially leading to fecal incontinence, abdominal discomfort, and bleeding. Although acute pouchitis may respond toAntibioticsResponds to treatment, butAntibioticsRefractory Pouchitis (Condition Resistant toAntibioticsTreatment without sufficient response may lead to frequent relapses. Antibiotic-refractory pouchitis affects 10-15% of pouchitis patients globally and can significantly impact their quality of life.

The positive opinion of the CHMP is based on the results of the EARNEST trial, with related data recently presented at the United European Gastroenterology Week Virtual 2021. The trial evaluated the safety and efficacy of Entyvio IV in treating active chronic pouchitis. The results showed that the study met its primary endpoint:At week 14 of treatment, the clinical remission rate was 31.4% in the Entyvio IV group and 9.8% in the placebo group.Moreover, information from extensive historical data retrospective studies suggests that Entyvio IV treatment may have a positive impact on patients with pouchitis.

Chinwe Ukomadu, Head of Gastroenterology at Takeda, said: "Takeda has made significant progress in advancing the treatment and care of patients with gastrointestinal diseases, and we welcome today's positive CHMP opinion for Entyvio IV in the treatment of pouchitis. Pouchitis is a chronic, debilitating condition that greatly impacts patients' quality of life. We are pleased to bring a new non-surgical treatment option to patients in Europe, where there are currently no approved treatments for this disease."

Entyvio is a gut-selective biologic, and its active ingredient vedolizumab is a fully humanized monoclonal antibody that specifically antagonizes α4β7 integrin, inhibiting the binding of α4β7 integrin to MAdCAM-1, a mucosal addressin cell adhesion molecule selectively expressed in the gastrointestinal vasculature and lymph nodes. α4β7 integrin is expressed on a subset of circulating white blood cells that have been shown to play a key role in mediating the inflammatory processes in CD and UC.

Entyvio Intravenous (IV) formulation was approved for marketing in the U.S. and EU in May 2014, for the treatment of patients who have had an inadequate response to conventional therapy orTumorAdult patients with moderate to severe active ulcerative colitis (UC) and Crohn's disease (CD) who have had an inadequate response to tumor necrosis factor-alpha (TNFα) antagonists. Currently, Entyvio intravenous (IV) formulation is marketed in more than 70 countries worldwide. UC and CD are the two most common types of inflammatory bowel disease (IBD).

In May 2020, Entyvio Subcutaneous (SC) formulation received approval from the European Commission (EC) as a maintenance therapy for the treatment of adult patients with moderate to severe Ulcerative Colitis (UC) and Crohn's Disease (CD). The Entyvio SC product line includes pre-filled syringes and pre-filled injection pens. Notably, Entyvio is the only approved maintenance therapy that offers both Intravenous (IV) and Subcutaneous (SC) formulations for adult patients with UC and CD, providing patients with more treatment options.

In China, Entyvio IV (Angiyou®, vedolizumab, injectable vedolizumab) was approved in March 2020 for the treatment of adult patients with moderately to severely active UC and CD who have had an inadequate response, lost response, or intolerance to conventional therapy or TNFα inhibitors.Entyvio (Angiyou®) was included in the first batch of clinically urgent overseas new drugs list and received expedited review.

Entyvio (Anjiyou®) is currently the only gut-selective biologic in the inflammatory bowel disease (IBD) field. Clinical data shows it can take effect quickly, achieve long-term clinical remission and mucosal healing, and has a good safety profile. It is recommended as a first-line biologic in European and American international guidelines.

From the inclusion of Entyvio® (vedolizumab for injection) in the first list of clinically urgent overseas new drugs to its rapid approval, this fully demonstrates the determination of the Chinese government to accelerate the introduction of innovative drugs and continuously improve the health of its people. The approval and market launch of this drug in China will provide a new treatment option for a large number of patients with moderate to severe IBD in China. (Bioon.com)