Glycopyrronium (1) – Axhidrox®
Severe primary axillary hyperhidrosis
Characteristics
| Start date | 01.08.2022 – Marketing authorisation: 01.06.2022 |
|---|---|
| Resolution | 19.01.2023 |
| INN | Glycopyrronium |
| Brand name | Axhidrox® |
| Pharm. company | Dr. August Wolff GmbH & Co. KG Arzneimittel |
| G-BA Procedure ID | D-850 |
| ATC code | D11AA01 Antihidrotics (D11AA) |
| DDD | 8.8 mg T |
| Therapeutic area | Other diseases |
| Reason for procedure | Initial assessment – New data exclusivity (known INN) |
Studies and Results
- Clinical trials
- The Hyp1-18/2016 study was a randomised, double-blind, placebo-controlled trial involving adults aged between 18 and 65 years with severe primary axillary hyperhidrosis.
- The Hyp-02/2015 study is a randomised, double-blind, placebo-controlled study in which glycopyrronium was administered at three different doses (0.5%, 1% and 2%).
Adults with severe primary axillary hyperhidrosis
- The additional benefit is not proven.
- In the overall review, no data suitable for benefit assessment are available. The additional benefit of glycopyrronium compared with the appropriate comparator therapy is therefore not proven for the indication ‘for the topical treatment of adults with severe primary axillary hyperhidrosis’.
- Overall assessment
- Overall, there are no data available that are suitable for a benefit assessment. The additional benefit of glycopyrronium compared with the appropriate comparator therapy is therefore not proven for the indication ‘for the topical treatment of adults with severe primary axillary hyperhidrosis’.
- In the overall assessment, the additional benefit of glycopyrronium compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Glycopyrronium (1) | Axhidrox® | Dr. August Wolff GmbH & Co. KG Arzneimittel | Severe primary axillary hyperhidrosis | 73,000–704,000 | 100% additional benefit not proven |
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