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drugalertJune 29 2016

Adempas (riociguat) should not be used in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonia or PH-IIP, the European Medicines Agency has warned.

Although the drug is not authorised for use in PH-IIP patients, the EMA has issued the recommendation following the early termination of a phase II clinical trial, RISE-IIP, investigating the effects of Adempas in this patient population.

“Preliminary results showed an increased number of deaths and serious adverse events, including breathing problems and lung infections, with Adempas compared with placebo. The available data do not indicate a clinically significant benefit from Adempas treatment in these patients,” said the EMA’s announcement, published on June 24.

The trial had been assessing the medicine in 145 PH-IIP patients, with the primary endpoint being the change in the 6-minute walking distance test after 6 months of treatment. “At the time of the interim assessment leading to the termination of the trial, 21 deaths had been observed, 17 patients taking Adempas and 4 patients taking placebo. Serious adverse events, which were mostly respiratory disease or lung infections, were also higher among patients taking Adempas.”

EMA is advising health professionals that “if any patients with PH-IIP are being treated with Adempas, this treatment should be discontinued and the patient’s clinical status carefully monitored.” A contraindication will also be included in prescribing information, and EMA will be issuing a letter to health professionals. 

It has also stated that Adempas continues to have a positive benefit-risk balance for its authorised uses.

The product’s indications in the UK are:

  • treating adults with WHO Functional Class (FC) II to III with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity
  • as monotherapy or in combination with endothelin receptor antagonists for adults with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity.

Links:

EMA announcement

Adempas SPC on eMC

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