Riociguat (3) – Adempas®
Pulmonary arterial hypertension (PAH)
Characteristics
| Start date | 15.03.2020 – Marketing authorisation: 27.03.2014 |
|---|---|
| Resolution | 03.09.2020 |
| INN | Riociguat |
| Brand name | Adempas® |
| Pharm. company | MSD SHARP & DOHME GMBH |
| G-BA Procedure ID | D-528 |
| ATC code | C02KX05 Antihypertensives for pulmonary arterial hypertension (C02KX) |
| DDD | 4.5 mg O |
| Therapeutic area | Cardiovascular diseases Orphan (turnover limit) |
| Reason for procedure |
New therapeutic indication
–
Orphan turnover exceeded
Original resolution: Riociguat (1) (16.10.2014) |
| Specialty | Bundling |
Studies and Results
- Clinical trials
- For the assessment of the additional benefit of riociguat, indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) in WHO functional classes (FC) II to III, to improve physical performance, the pharmaceutical manufacturer submitted the Phase III PATENT-1 randomised, double-blind, placebo-controlled, parallel-group trial, which formed the basis for marketing authorisation.
- In addition, the pharmaceutical manufacturer submitted the single-arm Phase III PATENT-2 extension study.
Adult patients with pulmonary arterial hypertension (PAH) in WHO functional classes (FC) II to III
- An additional benefit is not proven.
- Consequently, the pharmaceutical manufacturer did not submit any study for this patient population that would have been suitable for assessing the additional benefit of riociguat compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Riociguat (4) | Adempas® | MSD SHARP & DOHME GMBH | Pulmonary arterial hypertension, < 18 years of age | 5–35 | 100% additional benefit not proven | |
| Riociguat (2) | Adempas® | MSD SHARP & DOHME GMBH | Chronic thromboembolic pulmonary hypertension | 920–5,460 | 100% additional benefit not proven Orphan (turnover limit) | |
| Riociguat (3) | Adempas® | MSD SHARP & DOHME GMBH | Pulmonary arterial hypertension (PAH) | 580–7,850 | 100% additional benefit not proven Orphan (turnover limit) | |
| Riociguat (1) | Adempas® | Bayer Vital GmbH | Pulmonary arterial hypertension (PAH), Chronic thromboembolic pulmonary hypertension (CTPH) |
0
1,500–13,310 |
100% minor additional benefit Orphan repealed |
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