EMA gives green light to Actelion’s Uptravi after safety review
ZURICH The European Medicines Agency on Friday gave its green light for doctors to continue using Actelion’s Uptravi, saying a review after five patient deaths in France did not suggest an increase in mortality linked to the pulmonary arterial hypertension drug.
“No changes to the prescribing information are considered necessary,” said the agency, which initiated its review after France’s drug regulator in January issued a “Dear Doctor” letter recommending doctors not begin new Uptravi treatments pending an investigation.
Johnson & Johnson is in the midst of a $30 billion takeover of Actelion, which said this month the deal is on track to close in the second quarter.
(Reporting by John Miller; Editing by Michael Shields)