Olopatadin / Mometason (1) – Ryaltris®
Allergic rhinitis
Characteristics
| Start date | 01.12.2022 – Marketing authorisation: 17.11.2021 |
|---|---|
| Resolution | 01.06.2023 |
| INN | Olopatadin/Mometason |
| Brand name | Ryaltris® |
| Pharm. company | Berlin-Chemie AG |
| G-BA Procedure ID | D-880 |
| ATC code | R01AD59 Corticosteroids (R01AD) |
| ICD-10 codes (AIS) | J30.1Allergy NOS due to pollen, J30.2Other seasonal allergic rhinitis, J30.3, J30.4 |
| Alpha-ID codes (AIS) | I12707Allergic rhinosinusitis, I5089Allergic rhinitis due to pollen, I97226Non-seasonal allergic rhinitis, I97370Seasonal allergic rhinitis |
| Therapeutic area | Respiratory system diseases Chroinic rhinitis / rhinosinusitis (CRS) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
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|
Ryaltris is used in adults and adolescents aged 12 years and over for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults and children aged 12 years and over with moderate to severe nasal symptoms of allergic rhinitis | Intranasal glucocorticoid (INCS) in combination with intranasal antihistamine (INAH). |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (GSP301-PoC) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT (off-label)) |
- Clinical trials
- The GSP301-PoC study is a single-centre, double-blind, 5-arm randomised controlled trial (RCT).
Adults and children aged 12 years and over with moderate to severe nasal symptoms associated with allergic rhinitis
- Additional benefit is not proven for the treatment of adults and adolescents aged 12 years and over with moderate to severe nasal symptoms associated with allergic rhinitis.
- Overall, for adults and children aged 12 years and over with moderate to severe nasal symptoms associated with allergic rhinitis, the additional benefit of olopatadine/mometasone compared with the appropriate comparator therapy is not proven.
- Overall assessment / Conclusion
- In summary, the study submitted by the pharmaceutical manufacturer is not suitable for demonstrating any additional benefit of olopatadine/mometasone compared with the appropriate comparator therapy ‘intranasal glucocorticoid (INCS) in combination with an intranasal antihistamine (INAH)’.
- The study duration of only 14 days is considered too short within the context of the randomised comparative study phase for early benefit assessment in a chronic condition.
- Furthermore, it is unclear whether the results obtained under artificial induction can be extrapolated to the clinical setting under natural exposure.
Courtesy translation only, please refer to the German original.
Associated procedures
| Olopatadin / Mometason (1) | Ryaltris® | Berlin-Chemie AG | Allergic rhinitis | 3,807,000–7,356,000 | 100% additional benefit not proven |
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