The Withdrawal of Xiidra from European Consideration
In June 2020, Novartis withdrew its marketing authorization application for Xiidra in Europe, preventing its availability on the European market. This decision followed evaluations by the European Medicines Agency (EMA) that raised significant objections regarding the drug's efficacy and long-term data. While Xiidra was approved by the U.S. Food and Drug Administration (FDA) in 2016 based on the same clinical trial package, European regulators were not convinced of its benefits outweighing its risks.
The EMA's Rationale Behind the Decision
The EMA's assessment highlighted concerns that led to the application's withdrawal. The agency's provisional opinion was that the clinical data did not sufficiently demonstrate the drug's effectiveness for moderate-to-severe dry eye disease in adults. The EMA stated that the effectiveness of lifitegrast was not convincingly shown across different symptoms, and while some reduction in eye dryness was noted, it was not considered clinically significant.
Specific EMA concerns included:
- Insufficient evidence of effectiveness.
- Inadequate comparator in studies.
- Lack of long-term data.
- Unresolved issues that could not be addressed within the timeframe.
The Difference Between FDA and EMA Approval
The different outcomes for Xiidra between the FDA and EMA demonstrate the agencies' differing standards and evaluation criteria. The EMA applied a stricter interpretation of the evidence, particularly regarding clinical significance and long-term implications for a chronic disease. This variation in approval is not uncommon between regulatory bodies.
European Alternatives to Xiidra
Several approved alternatives to lifitegrast are available in Europe for dry eye disease. These include cyclosporine formulations, artificial tears, corticosteroid drops for short-term use, and medical devices. Patients should consult with a healthcare provider to discuss appropriate treatment options.
Comparison of Xiidra (US) and a European Alternative
The table below compares Xiidra with Ikervis (cyclosporine), an EMA-approved alternative:
| Feature | Xiidra (Lifitegrast) in the US | Ikervis (Cyclosporine) in the EU |
|---|---|---|
| Regulatory Status | FDA-approved for dry eye disease | EMA-approved for severe keratitis in dry eye disease |
| Active Ingredient | Lifitegrast | Cyclosporine |
| Mechanism | LFA-1 antagonist, blocks inflammation | Calcineurin inhibitor, immunosuppressant |
| Availability in Europe | Not available | Available |
| Company | Bausch + Lomb (in the US) | Santen Pharmaceutical (in the EU) |
| Onset of Action | Some symptom improvement within weeks | Can take several months for significant effect |
Conclusion
In summary, Xiidra is not available in Europe due to the withdrawal of its marketing application in 2020. The EMA concluded that Xiidra's benefits did not outweigh its risks, citing concerns about insufficient evidence of clinical effectiveness and lack of long-term safety data. European patients can explore alternative dry eye treatments available within the EU. Consulting with an ophthalmologist is recommended to determine the best course of action. A future submission for approval in Europe would require a new application with additional data to address the EMA's concerns.
