EMA reviews Actelion PAH drug after patient deaths

Dive Brief:

  • The European Medicines Agency has launched a safety review of Actelion Pharma's pulmonary arterial hypertension medicine Uptravi (selexipag) to investigate the deaths of 5 patients taking the drug in France.
  • The agency's Pharmacovigilance Risk Assessment Committee will lead the review, which stems from an alert by the French drugs regulator, ANSM, that was sent out to physicians last month. 
  • New and existing patients can continue to take Uptravi, the EMA said, although it cautioned doctors carefully follow existing prescribing information. 

Dive Insight:

A new safety signal on one of Actelion's most important drugs is probably not what Johnson & Johnson wanted to hear in the weeks following its $30 billion acquisition of the Swiss company's PAH portfolio.

The EMA will publish conclusions upon completion of the safety review. Until then, the EMA says Uptravi can continue to be used in new and existing patients. 

Actelion had no comment on the deaths when reached by BioPharma Dive. 

Common side effects for Uptravi include headache, nausea, vomiting, myalgia and others. The EMA warns against use of the drug in patients with severe coronary heart disease, severe arrhythmias, or those patients who have recently had a heart attack. 

As sales of Actelion's current top-earner Tracleeer(bosentan) fall due to generic competition, Uptravi and Actelion's other PAH drug, Opsumit (macitentan), will be the main drivers of growth moving forward.

Combined annual sales of Uptravi and Opsumit overtook those of Tracleer in 2016, as Uptravi continues to build quickly in the U.S. And Uptravi, which carries a hefty price tag of about $160,000, is forecast to hit sales of $1 billion by 2019, according to analysts surveyed by Bloomberg.

PAH is life-threatening but rare, affecting only around 15 to 50 per million of the population, but is more common in certain groups, including people with HIV, systemic sclerosis or sickle cell disease.

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Filed Under: Regulatory / Compliance Corporate News
Top image credit: Actelion