Rimegepant (1) – Vydura®
Acute treatment of migraine
Characteristics
| Start date | 01.06.2025 – Marketing authorisation: 25.04.2025 |
|---|---|
| Resolution | 20.11.2025 |
| INN | Rimegepant |
| Brand name | Vydura® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-1201 |
| ATC code | N02CD06 CGRP antagonists (N02CD) |
| Therapeutic area | Nervous system diseases |
| Reason for procedure | Initial assessment |
Studies and Results
- Clinical trials
- To assess the additional benefit of rimegepant for use in the acute treatment of migraine headaches with or without aura, the pharmaceutical manufacturer has submitted the placebo-controlled registration trials BHV3000-301, BHV3000-302 and BHV3000-303.
Adults with migraine, with or without aura, who require acute treatment for migraine headaches
- The additional benefit is not proven.
- Due to the lack of a comparison between rimegepant and the appropriate comparator therapy, the studies submitted are not suitable for assessing additional benefit.
- An additional benefit of rimegepant compared with the appropriate comparator therapy is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Rimegepant (2) | Vydura® | Pfizer Pharma GmbH | Migraine prophylaxis | 1,386,900–1,726,200 | 100% additional benefit not proven | |
| Rimegepant (1) | Vydura® | Pfizer Pharma GmbH | Acute treatment of migraine | 2,825,000 | 100% additional benefit not proven |
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