dm+d

704257002

Articles

Safety in lactation: Drugs for chronic bowel disorders

21 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Aminosalicylates for chronic bowel disorders Mesalazine…
Search Articles

Refrigerated Storage

EntyvioTakeda

Takeda
Entyvio
300 mg powder for concentrate for solution for infusion

Contact Takeda in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

30 September 2020
London Medicines Information

EntyvioTakeda

Takeda
Entyvio
108mg solution for injection in pre-filled syringe/pre-filled pen

Contact Takeda in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

30 September 2020
London Medicines Information

Lactation Safety Information

See summary
Limited published evidence of safety indicates small amounts in breast milk which are likely to be degraded in the infant’s GI tract
Very long half-life increases risk of accumulation in breastfed infants
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
15 September 2019

New Medicines

EntyvioCrohns disease and ulcerative colitis - subcutaneous formulation

Information

Entyvio
New formulation
Takeda
Takeda

Development and Regulatory status

Launched
Launched
Not approved
June 2020
Jun 20Launched in UK. List price per 108mg pre-filled syringe or pen is £512.50 [14].
May 20The EC has granted a Marketing Authorization for the subcutaneous (SC) formulation of vedolizumab for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease [14].
Feb 20CHMP has recommended a change to the terms of the Marketing Authorisation: this adds a new pharmaceutical form, a 108 mg solution for subcutaneous injection that will be used as maintenance treatment for all authorised indications of the medicine [13].
Dec 19Takeda has received a Complete Response Letter from the U.S. FDA in response to its BLA for approval of an investigational subcutaneous formulation of vedolizumab for maintenance therapy in adults with moderate to severe ulcerative colitis (UC). It plans to work closely with the FDA on a path to approval [12].
May 19Filed in US. Application is based on results of VISIBLE 1 RCT (n=216), in which a higher proportion of patients receiving vedolizumab s/c 108 mg maintenance therapy every 2 weeks achieved clinical remission compared to those receiving placebo (46.2% vs. 14.3%; p<0.001) at week 52 [9].
Apr 19Filed in EU [8]
Jul 16PIII in EU & US [1].

Category

Humanised monoclonal antibody to alpha4β7 integrin
In 2010, there were around 79,115 adults in England with Crohn’s disease, of whom ~50% (39,557) are resistant or intolerant to conventional therapies. About two in 1,000 people in the UK develop UC. It can develop at any age but most commonly first develops between the ages of 10 and 40. The prevalence is about 120,000 to 150,000 people; ~50% will experience a relapse in any year.
Crohns disease and ulcerative colitis - subcutaneous formulation
Subcutaneous injection

Trial or other data

May 19Takeda present additional results from PIIIb VARSITY study (n=769) at conference. At week 14 a larger proportion of patients receiving vedolizumab had a clinical response compared to those receiving adalimumab (67.1% vs 45.9% respectively) [10].
Mar 19PIIIb VARSITY trial found vedolizumab superior to adalimumab in achieving clinical remission in patients with moderate to severe active ulcerative colitis at week 52. Of those treated with vedolizumab IV, 31.3% (n=120/383) achieved clinical remission (primary endpoint ) compared to 22.5% (n=87/386) of those treated with adalimumab subcutaneous (SC), (p=0.0061) [7].
Oct 18Results from PIII VISIBLE 1 study announced at conference. At week 52, a statistically significant proportion of patients on SC vedolizumab achieved clinical remission compared to patients receiving placebo (46.2% vs. 14.3%; p<0.001). A similar rate of clinical remission was observed in vedolizumab IV reference arm (42.6%) [6].
Sep 18Commissioned by CCGs for adults, NHS England for children [5].
Jul 18PIII VISIBLE-1 study (n=384) of vedolizumab for maintenance of UC achieves primary endpoint. Signifcantly more patients receiving vedolizumab achieved clinical remission at week 52 vs placebo. Safety data were consistent with IV vedolizumab (Entyvio) [4].
Aug 16PIII trials (NCT02611830 and NCT02611817) are due to complete collecting primary outcome data in Aug 18 and Mar 2020, respectively [3].
Apr 16Extension PIIIb trial to assess long-term safety and tolerability of vedolizumab 108mg SC in patients with ulcerative colitis (UC) and Crohn´s disease (CD) and have previously participated in the two PIII studies that started in Jan 16 starts (NCT02620046) [2].
Jan 16Takeda initiates a PIII trial to assess safety and efficacy of vedolizumab 108mg SC injection q2w as maintenance treatment in patients with moderately to severely active Crohn´s disease (CD), who achieved clinical response following vedolizumab 300mg IV infusion induction therapy (NCT02611817). The double-blind, randomised, placebo-controlled, parallel group trial will enrol approximately 824 patients (aged 18 to 80 years); recruitment is underway in the US and Slovakia, and may expand to Australia, Belgium, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, the Czech Republic, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Mexico, the Netherlands, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Sweden, Turkey, Ukraine and the UK [2].
Jan 16Takeda initiates a PIII trial to assess safety and efficacy of vedolizumab 108mg SC injection q2w as maintenance treatment, with a vedolizumab IV reference arm, in patients with moderately to severely active ulcerative colitis, who achieved clinical response following vedolizumab 300mg IV infusion q8w induction therapy (NCT02611830). The double-blind, randomised, placebo-controlled, parallel group trial will enrol approximately 400 patients (aged 18 to 80 years) in Belgium, Bulgaria, Croatia, the Czech Republic, Denmark, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, the Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden, the US and the UK [2].

Evidence based evaluations

EntyvioAcute intestinal graft versus host disease (GvHD) - prevention in patients aged 12 years and older undergoing allogenic haematopoietic stem cell (allo-HSCT) transplantation as treatment for a haematologic malignancy or myeloproliferative disorder

Information

Entyvio
Licence extension / variation
Takeda
Takeda

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A humanised monoclonal antibody that specifically targets α4β7 integrin and inhibits its adhesion to mucosal addressin cell adhesion molecule 1 (MAdCAM-1), thereby demonstrating gut-selective immunomodulatory activity.
About 35%-50% of hematopoietic stem cell transplant (HSCT) recipients will develop acute Graft versus host disease (GVHD). Given the number of transplants performed, it is estimated that about 5500 patients/year will develop acute GVHD [1].
Acute intestinal graft versus host disease (GvHD) - prevention in patients aged 12 years and older undergoing allogenic haematopoietic stem cell (allo-HSCT) transplantation as treatment for a haematologic malignancy or myeloproliferative disorder
Intravenous infusion