Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Overview Summary
Comprehensive product overview and regulatory summary
Orladeyo is a medicine used to prevent attacks of hereditary angioedema (swelling) in patients from 12 years of age. Patients with hereditary angioedema have attacks of rapid swelling such as in the face, throat, arms and legs, or around the gut.
Hereditary angioedema is rare, and Orladeyo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 27 June 2018. Further information on the orphan designation can be found here.
Orladeyo contains the active substance berotralstat.
Active Substances (1)
berotralstat dihydrochloride
Documents (14)
Orladeyo: EPAR - Product information
June 1, 2021
DRUG_PRODUCT_INFORMATION
Orladeyo : EPAR - Procedural steps taken and scientific information after authorisation
July 12, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Orladeyo : EPAR - Public assessment report
June 1, 2021
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
CHMP summary of positive opinion for Orladeyo
February 26, 2021
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Orladeyo : Orphan designation withdrawal assessment report (initial authorisation)
June 1, 2021
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Orladeyo-H-C-5138-P46-004 : EPAR - Assessment report
February 13, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Orladeyo-H-C-5138-P46-005 : EPAR - Assessment report
July 12, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Orladeyo : EPAR – Medicine overview
June 1, 2021
OVERVIEW_DOCUMENT
Orladeyo : EPAR - Risk-management-plan summary
June 1, 2021
RISK_MANAGEMENT_PLAN_SUMMARY
Orladeyo : EPAR - All authorised presentations
June 1, 2021
AUTHORISED_PRESENTATIONS
Orladeyo : Orphan designation withdrawal assessment report (initial authorisation)
June 1, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Orladeyo : EPAR - Public assessment report
June 1, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Orladeyo
February 26, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Orladeyo-H-C-PSUSA-00010930-202312 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
September 23, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (7)
Question
How is Orladeyo used?
Answer
Orladeyo is available as capsules and can only be obtained with a prescription. The recommended dose is one 150-mg capsule daily taken with food.
For more information about using Orladeyo, see the package leaflet or contact your healthcare provider.
Question
How does Orladeyo work?
Answer
The active substance in Orladeyo, berotralstat, works by blocking the activity of a protein called kallikrein. In patients with angioedema, overactive kallikrein leads to raised levels of another protein, bradykinin. Bradykinin is involved in a process that causes blood vessels to widen and become leaky. resulting in the swelling and inflammation of angioedema attacks. Blocking the activity of kallikrein reduces the number of these attacks.
Question
What benefits of Orladeyo have been shown in studies?
Answer
Orladeyo was effective at preventing attacks of angioedema in one main study of 121 patients with hereditary angioedema. Patients taking 150 mg Orladeyo every day for 24 weeks had an average of 1.3 attacks per month, compared with 2.4 attacks per month in patients taking placebo (a dummy treatment).
Question
What are the risks associated with Orladeyo?
Answer
The most common side effects with Orladeyo (which may affect more than 1 in 10 people) are headache, abdominal (belly) pain and diarrhoea. Abdominal pain and diarrhoea, which can occur about 1 to 3 months after starting Orladeyo, get better as treatment continues.
For the full list of side effects and restrictions with Orladeyo, see the package leaflet.
Question
Why is Orladeyo authorised in the EU?
Answer
Orladeyo is effective at reducing the number of angioedema attacks, including life-threatening throat swelling. The medicine can be taken by mouth and its side effects were manageable. The European Medicines Agency therefore decided that Orladeyo’s benefits are greater than its risks and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Orladeyo?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Orladeyo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Orladeyo are continuously monitored. Side effects reported with Orladeyo are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Orladeyo
Answer
Orladeyo received a marketing authorisation valid throughout the EU on 30 April 2021.