Trepulmix

treprostinil sodium

Table of contents

Opinion

On 30 January 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Trepulmix1, intended for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). The applicant for this medicinal product is SciPharm Sarl.

Trepulmix will be available as 1 mg/ml, 2.5 mg/ml, 5 mg/ml and 10 mg/ml solutions for infusion. The active substance of Trepulmix is treprostinil sodium, a prostacyclin analogue which has a direct vasodilatory effect on the pulmonary and systemic arterial circulation and inhibits platelet aggregation.

The benefits with Trepulmix is its ability to provide significant improvement in exercise capacity in patients with CTEPH. The most common side effects are headache, diarrhoea, nausea, jaw pain and infusion site pain.

Trepulmix is a hybrid medicine2 of Remodulin which has been authorised in the EU since 10 August 2005 and contains the same active substance. Remodulin is licensed for the treatment of pulmonary arterial hypertension.

The full indication is:

“Treatment of adult patients with WHO Functional Class (FC) III or IV and:

  • inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or
  • persistent or recurrent CTEPH after surgical treatment

to improve exercise capacity.”

Treatment with Trepulmix should be started and monitored only by clinicians experienced in the treatment of pulmonary hypertension. Treatment should be started under close medical supervision in a medical facility where intensive care can be provided.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


This product was designated as orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

2 Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.

Key facts

Name
Trepulmix
Agency product number
EMEA/H/C/005207
International non-proprietary name (INN) or common name
  • treprostinil sodium
Active substance
  • Treprostinil sodium
Therapeutic area
Hypertension, Pulmonary
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
30/01/2020
Company name
SciPharm Sàrl
Status
Positive
Application type
Initial authorisation

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