Riociguat (2) – Adempas®

Chronic thromboembolic pulmonary hypertension

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-527
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
    • To assess the additional benefit of riociguat for the treatment of adult patients in WHO functional classes (FC) II to III with inoperable CTEPH, or persistent or recurrent CTEPH following surgical treatment, to improve physical performance, the pharmaceutical manufacturer submitted the randomised, double-blind, placebo-controlled Phase III CHEST-1 trial, which formed the basis for marketing authorisation.
    • In addition, the pharmaceutical manufacturer submitted the single-arm Phase III CHEST-2 extension study.

Adult patients in WHO functional classes (FC) II to III with inoperable CTEPH, or persistent or recurrent CTEPH following surgical treatment

  • The 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



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