Lytenava
Opinion
EMA has issued an opinion on this medicine
bevacizumab
MedicineHumanOpinion
Overview
On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lytenava, intended for treatment of neovascular (wet) age-related macular degeneration (nAMD).
The applicant for this medicinal product is Outlook Therapeutics Limited.
Lytenava will be available as 25 mg/ml solution for injection. The active substance of Lytenava is bevacizumab gamma, a humanised monoclonal antibody (ATC code: S01LA08) that binds to the vascular endothelial growth factor (VEGF) and prevents its activity.
The benefit of Lytenava is the preservation of vision in patients with wet AMD as measured in studies by best-corrected visual acuity. The most common side effects are conjunctival haemorrhage, eye pain, vitreous floaters and intraocular pressure increase.
The full indication is:
Lytenava is indicated in adults for treatment of neovascular (wet) age-related macular degeneration (nAMD).
Lytenava must be administered by qualified healthcare professional, experienced in intravitreal injections.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
Product details
- Name of medicine
- Lytenava
- Active substance
- bevacizumab
- International non-proprietary name (INN) or common name
- bevacizumab
- Therapeutic area (MeSH)
- Wet Macular Degeneration
- Anatomical therapeutic chemical (ATC) code
- S01LA
- EMA product number
- EMEA/H/C/005723
- Marketing authorisation applicant
- Outlook Therapeutics Limited
- Opinion adopted
- 21/03/2024
- Opinion status
- Positive
News on Lytenava
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