Omlyclo is a medicine used to improve the control of severe persistent asthma caused by an allergy. It is used as an add-on to asthma treatment in patients from 6 years of age when the asthma is caused by an antibody called immunoglobulin E (IgE). Omlyclo should only be used in patients who: - have had a positive skin test result for an allergy caused by an allergen (a substance that causes an allergy) in the air, such as house-dust mites, pollen or mould; - have frequent symptoms during the day or waking up during the night; - have had many severe asthma attacks despite treatment with high doses of inhaled corticosteroids plus a long-acting inhaled beta-2 agonist (other medicines to treat asthma). In patients aged 12 years or over, Omlyclo should only be used if the patient has reduced lung function (measured as less than 80% of their FEV1, the maximum volume of air they can breathe out in 1 second). Omlyclo is also used to treat: - chronic (long-term) spontaneous urticaria (itchy rash). It is used as an add-on to existing treatment in patients aged 12 years or over in whom treatment with an antihistamine (another medicine to treat urticaria) does not work well enough; - severe chronic rhinosinusitis with nasal polyps (inflamed lining of the nose and sinuses with swellings in the nose) in adults. It is used with a corticosteroid given into the nose when the corticosteroid alone does not work well enough. Omlyclo contains the active substance omalizumab and is a biological medicine. It is a biosimilar medicine; this means that it is highly similar to another biological medicine (the reference medicine) that is already authorised in the EU. The reference medicine for Omlyclo is Xolair. For more information on biosimilar medicines, see [here](https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines).
Therapeutic Indication
### Therapeutic indication **Allergic asthma** Omlyclo is indicated in adults, adolescents and children (6 to <12 years of age). Omlyclo treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2). Adults and adolescents (12 years of age and older) Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Children (6 to <12 years of age) Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. **Chronic rhinosinusitis with nasal polyps (CRSwNP)** Omlyclo is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control. **Chronic spontaneous urticaria (CSU)** Omlyclo is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.
Therapeutic Area (MeSH)
ATC Code
R03DX05
ATC Item
omalizumab
Pharmacotherapeutic Group
Drugs for obstructive airway diseases
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| omalizumab | N/A | 奥马珠单抗 |
EMA Name
Omlyclo
Medicine Name
Omlyclo
Aliases
N/ANo risk management plan link.
