The European Medicines Agency told doctors today that they can continue to prescribe Actelion‘s (VTX:ATLN) pulmonary arterial hypertension drug, Uptravi. The regulatory body initiated a safety review in January after 5 patients in France died and docs were asked to stop prescribing the drug.
Regulators reported that their review did not suggest an increase in mortality linked to Uptravi. The drug is Actelion’s 3rd best-seller, accounting for nearly 10% of the company’s 2016 sales.
“No changes to the prescribing information are considered necessary,” said the agency, according to Reuters.
The news is likely reassuring to Johnson & Johnson (NYSE:JNJ), since the U.S. healthcare giant is in the middle of a $30 billion takeover of Actelion. The takeover is on track to close in the 2nd quarter.
Also this week, Actelion shareholders approved spinning off the company’s early clinical assets and drug discovery branch into a new company.
The newly formed biopharmaceutical company will be called Idorsia Ltd and will be led by Actelion CEO Jean-Paul Clozel. Shares in Idorsia are expected to list on the SIX Swiss Exchange on the day that Johnson & Johnson’s tender offer closes.
J&J will initially hold 16% of Idorsia shares, the U.S. healthcare giant said. It plans to de-list Actelion.
J&J will have 10 more trading days, between April 6 and April 21, for the subsequent acceptance of the tender offer, according to the company.