EU/3/07/518

About

On 20 December 2007, orphan designation (EU/3/07/518) was granted by the European Commission to Bayer HealthCare AG, Germany, for Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4 b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate for the treatment of pulmonary arterial hypertension including chronic thromboembolic pulmonary hypertension.

The sponsorship was transferred to Bayer Schering Pharma AG, Germany, in April 2009. Bayer Shering Pharma AG changed its name to Bayer Pharma AG in October 2011.

The sponsorship was transferred to Bayer AG, Germany, in August 2017.

Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate has been authorised in the EU as Adempas since 27 March 2014.

This medicine is now known as riociguat.

Key facts

Active substance
Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate (riociguat)  
Medicine name
Adempas
Disease / condition
Treatment of pulmonary arterial hypertension
Date of decision
20/12/2007
Outcome
Positive
Orphan decision number
EU/3/07/518

Review of designation

During its meeting of 4 to 6 February 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/07/518 for Adempas (riociguat1) as an orphan medicinal product for the treatment of pulmonary arterial hypertension including chronic thromboembolic pulmonary hypertension. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other satisfactory methods of treatment. As other methods of treatment for patients with this condition are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. The COMP recommended that the orphan designation of the medicine be maintained2.


1Previously known as methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4 b]pyridine-3-yl]-5-pyrimidinyl(methyl) carbamate.

2The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.

Sponsor's contact details

Bayer AG
51368 Leverkusen
Germany
Tel. +49 30 300 139 003
E-mail: clinical-trials-contact@bayer.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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