dm+d
35299711000001103
Articles
Medicines that are considered safe for use in the acute porphyrias
29 May 2020The UK Porphyria Medicines Information Service (UKPMIS) and Cardiff Porphyria Service produce a list of medicines that are considered to be safe for use in…
Refrigerated Storage
FasenraAstraZeneca
AstraZeneca
Fasenra
30 mg solution for injection in pre filled syringe
In the event of an inadvertent temperature excursion the following data may be used:
The product is stable when exposed to a single temperature excursion of 0°C to 2°C for a maximum of 24 hours or 8°C to 40°C for a maximum of 24 hours.
When exposed to excursions falling within these parameters, the item can be returned to the recommended storage conditions of 2-8°C and no change in expiry date is required.
Healthcare professionals should contact AstraZeneca Medical Information on an individual basis if the excursion falls outside of the durations and temperature ranges specified above.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
No
Yes
25 March 2021
London MI Service
New Medicines
FasenraEosinophilic oesophagitis in patients aged 12 years and older
Information
Fasenra
Licence extension / variation
AstraZeneca
MedImmune
Development and Regulatory status
Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Category
Monoclonal antibody binding to the interleukin-5 receptor that depletes eosinophils
In 2013, eosinophilic oesophagitis was considered to affect less than 5 in 10,000 people in the EU [1]. Studies suggest that the prevalence is rising, but it is uncertain whether this is a true increase or due to better diagnosis; it is most common in middle-aged men [2].
Eosinophilic oesophagitis in patients aged 12 years and older
Subcutaneous injection
Further information
Yes
Evidence based evaluations
FasenraSevere bilateral chronic sinusitis with nasal polyps in patients who are symptomatic despite standard therapy
Information
Fasenra
Licence extension / variation
AstraZeneca
MedImmune
Development and Regulatory status
None
Phase III Clinical Trials
Not recommended for approval (Negative opinion)
Mar 22FDA has issued a complete response letter for the use of benralizumab in chronic sinusitis with nasal polyps. Additional clinical data has been requested. AstraZeneca is working closely with FDA and is planning another PIII trial (ORCHID). Data is expected in the second half of 2023 [9]
Sep 21According to the company ´s latest annual report, EU filing is planned for 2022 [8].
Jul 21Currently pre-registration in the US [6].
Mar 21Following an update from the company that market benralizumab, NICE will not be progressing with its scoping exercise at this stage. Latest plans for UK availability are unknown [7].
Sep 19Filings will be in 2021 [3].
Sep 18Filings based on OSTRO study planned for 2020 or later [2].
Category
Monoclonal antibody binding to the interleukin-5 receptor that depletes eosinophils
The population prevalence of nasal polyps is reported as 2-4%, with no racial predilection. The male to female ratio has been reported at approximately 2:1
Severe bilateral chronic sinusitis with nasal polyps in patients who are symptomatic despite standard therapy
Subcutaneous
Further information
Yes
Trial or other data
Mar 22A randomised double blind placebo controlled parallel group multi-centre PIII trial (ORCHID, NCT04157335) is planned to evaluate the efficacy and safety of repeat dosing of benralizumab 30mg administered subcutaneously vs placebo in pts with severe nasal polyps over 56 weeks (n=276). Primary outcome measures include change in baseline in endoscopic total nasal polyp score and mean nasal blockage score. Estimated primary completion date is Sep 2023 [9, 10]
Sep 20Both co-primary endpoints of reduced nasal polyp size and blockage met in PIII OSTRO trial in patients with chronic rhinosinusitis with nasal polyps [5]
Oct 19Recruitment completed for the OSTRO trial. Estimated primary completion date is Aug 2020 [4].
Jun 18First patient commences dosing in PIII OSTRO trial (NCT03401229). 400 patients will be recruruited from 8 countries comparing benralizumab 30mg every 8 weeks with placebo over 56 weeks. Primary outcome is nasal polyp burden and patient-reported nasal blockage. Data anticipated 2020 [1].
Evidence based evaluations
FasenraEosinophilic granulomatosis with polyangiitis
Information
Fasenra
Licence extension / variation
AstraZeneca
MedImmune
Development and Regulatory status
Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Category
Fully humanised IgG monoclonal antibody specific for interleukin 5 (IL-5)
Eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss Syndrome, is an inflammatory disease of small and medium sized blood vessels. The lungs and skin are commonly affected but it can affect other organs including the heart, kidneys, nerves and bowels. EGPA seems to affect men and women equally. Around 11-13 people per million are diagnosed with EGPA [1].
Eosinophilic granulomatosis with polyangiitis
Subcutaneous injection
FasenraChronic obstructive pulmonary disease (COPD)
Information
Fasenra
Licence extension / variation
AstraZeneca
MedImmune
Development and Regulatory status
Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Category
Monoclonal antibody binding to the interleukin-5 receptor that depletes eosinophils
An estimated three million people are affected by COPD in the UK. About 900,000 have been diagnosed with COPD and an estimated two million people have COPD which remains undiagnosed. The rate of COPD in the population is estimated at between 2% and 4%. The diagnosed prevalence of COPD is 1.5%. The prevalence increases with age, with an estimated prevalence of 10% in men older than 75.
Chronic obstructive pulmonary disease (COPD)
Subcutaneous
Evidence based evaluations
FasenraEosinophilic gastroenteritis (EG) - with or without eosinophilic gastroenteritis (EGE)
Information
Fasenra
Licence extension / variation
AstraZeneca
MedImmune
Development and Regulatory status
None
Phase III Clinical Trials
Phase III Clinical Trials
Category
Monoclonal antibody binding to the interleukin-5 receptor that depletes eosinophils
A rare disorder characterised by oeosinophilic infiltration of the stomach (EG) or stomach and small intestine (EGE) with various gastrointestinal manifestations. Incidence is approximately 10/100,000 with peak prevalence in children and adults aged 20-50 years [1,2].
Eosinophilic gastroenteritis (EG) - with or without eosinophilic gastroenteritis (EGE)
Subcutaneous injection