Orladeyo
Authorised
This medicine is authorised for use in the European Union
berotralstat
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Orladeyo is a medicine used to prevent attacks of hereditary angioedema (HAE) in people from 2 years of age who weigh at least 15 kg. People with HAE have attacks of rapid swelling such as in the face, throat, arms and legs, or around the gut.
Orladeyo contains the active substance berotralstat.
Orladeyo can only be obtained with a prescription and is available as capsules and film-coated granules in a sachet.
The film-coated granules are used in children from 2 to less than 12 years of age who weigh at least 15 kg and in adolescents aged 12 years and older who weigh less than 40 kg. Orladeyo is taken as one sachet once daily with food, with the recommended dose depending on the patients’ body weight.
Orladeyo capsules are for use in adults and adolescents aged 12 years and older who weight at least 40 kg. The recommended dose is one capsule taken once daily with food.
HAE can be caused by low levels or impaired functioning of a protein known as C1 esterase inhibitor (type I and type II HAE). However, some people with HAE have normal levels of C1 esterase inhibitor which functions normally. This form of HAE is known as HAE with normal C1 esterase inhibitor (nC1-INH HAE). If patients with nC1-INH HAE do not respond to treatment and if they have not had a reduction in attacks after 3 months of treatment, their doctor should consider stopping treatment with Orladeyo.
For more information about using Orladeyo, see the package leaflet or contact your doctor or pharmacist.
The active substance in Orladeyo, berotralstat, works by blocking the activity of a protein called kallikrein. In patients with type I or II HAE, low levels or poor functioning of C1 esterase inhibitor lead to increased kallikrein activity. This 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 seen in angioedema attacks. Blocking the activity of kallikrein reduces the number of these attacks.
Orladeyo was effective at preventing attacks of angioedema in one main study of 121 adult and adolescent patients with hereditary angioedema. Patients taking 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).
Additional data showed that when Orladeyo is given to children aged 2 to less than 12 years and adolescents at the recommended doses for their age and body weight, it behaves in the same way in children as it does in adults.
Studies carried out with Orladeyo are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions with Orladeyo, see the package leaflet.
The most common side effects with Orladeyo (which may affect more than 1 in 10 people) include 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.
Orladeyo is effective at reducing the number of angioedema attacks, including life-threatening throat swelling, in adults and children from 2 years of age. The medicine can be taken by mouth and its side effects were considered 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.
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.
Orladeyo received a marketing authorisation valid throughout the EU on 30 April 2021.
Product information
Latest procedure affecting product information:X/0000268892
27/08/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Orladeyo
- Active substance
- berotralstat dihydrochloride
- International non-proprietary name (INN) or common name
- berotralstat
- Therapeutic area (MeSH)
- Angioedemas, Hereditary
- Anatomical therapeutic chemical (ATC) code
- B06AC06
Pharmacotherapeutic group
Other hematological agentsTherapeutic indication
Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older weighing at least 40 kg.
Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in:
- children aged 2 to less than 12 years weighing at least 15 kg
- adolescents aged 12 and older weighing less than 40 kg
News on Orladeyo
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