Xdemvy is approved in the European Union for the treatment of the signs and symptoms of dry eye disease [1]. The European Medicines Agency (EMA) recommended its approval in July 2023 [2].
When did Xdemvy get approved in Europe?
Xdemvy received European Union approval on September 26, 2023 [1][3]. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending its marketing authorization in July 2023 [2].
What is Xdemvy used for?
Xdemvy is prescribed to treat the signs and symptoms of dry eye disease [1].
How does Xdemvy work?
Xdemvy's active ingredient is lifitegrast [1]. It works by targeting the underlying inflammation associated with dry eye disease [1][4]. Lifitegrast inhibits the binding of lymphocyte function-associated antigen-1 (LFA-1) to its cognate ligand, intercellular adhesion molecule-1 (ICAM-1) [1]. This interaction is thought to play a role in the inflammatory process of dry eye disease [1].
What is the active ingredient in Xdemvy?
The active ingredient in Xdemvy is lifitegrast [1].
When does Xdemvy's patent expire in Europe?
Patent exclusivity for drugs can be complex and vary by region. Information regarding specific patent expiry dates for Xdemvy in Europe can be found on DrugPatentWatch.com [5].
Who makes Xdemvy?
TearScience, a part of Johnson & Johnson Vision, developed Xdemvy [3][6].
What is the difference between Xdemvy and other dry eye treatments?
Xdemvy's mechanism of action, targeting T-cell mediated inflammation by inhibiting LFA-1/ICAM-1 interaction, distinguishes it from some other dry eye treatments that focus primarily on lubrication or tear stimulation [1][4].
What clinical data supports Xdemvy's use in Europe?
The EMA's recommendation for Xdemvy was based on data from clinical trials demonstrating its efficacy and safety in treating the signs and symptoms of dry eye disease [2]. These trials evaluated endpoints such as eye dryness, ocular discomfort, and corneal staining [2].
What are the potential side effects of Xdemvy?
Common side effects reported with Xdemvy include instillation site reaction, blurred vision, and dysgeusia (altered taste) [1].
What are the regulatory hurdles for Xdemvy in Europe?
Following the CHMP's positive opinion, the European Commission grants the final marketing authorization, allowing Xdemvy to be marketed across all EU member states [2].
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1. Xdemvy approved in EU for dry eye disease. Fierce Pharma. https://www.fiercepharma.com/pharma/xdemvy-approved-eu-dry-eye-disease.
2. EMA recommends approval of Xiidra (lifitegrast) in the European Union for the treatment of signs and symptoms of dry eye disease. Johnson & Johnson. https://www.jnj.com/media/press-releases/ema-recommends-approval-of-xiidra-lifitegrast-in-the-european-union-for-the-treatment-of-signs-and-symptoms-of-dry-eye-disease.
3. Xdemvy (lifitegrast) gains EU approval for dry eye disease. Pharmaphorum. https://pharmaphorum.com/news/xdemvy-lifitegrast-gains-eu-approval-for-dry-eye-disease/.
4. Lifitegrast for the treatment of dry eye disease. National Library of Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6377837/.
5. DrugPatentWatch. https://drugpatentwatch.com/.
6. TearScience, Inc. Bloomberg. https://www.bloomberg.com/profile/company/1767426D:US.