Omlyclo (omalizumab)
- Region
- 🇪🇺 EU
- Active substance
- omalizumab
- Company
- Celltrion Healthcare Hungary Kft.
- Status
- Authorised
- Therapeutic area
- Asthma; Urticaria
- CHMP opinion
- Thu 21 Mar 2024
- EU approval
- Thu 16 May 2024
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/005958
- ATC
- R03DX05
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.