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EMA gives green light to Actelion's Uptravi after safety review
April 7, 2017 / 11:52 AM / 8 months ago

EMA gives green light to Actelion's Uptravi after safety review

ZURICH (Reuters) - 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.

Swiss biotech company Actelion's logo is seen on a package of Uptravi medications displayed at the company's headquarters in Allschwil, Switzerland January 26, 2017. REUTERS/Arnd Wiegmann

“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

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