The European Medicines Agency in February said it would take a hard look at the safety of Actelion’s new pulmonary arterial hypertension med Uptravi following five patient deaths in France. Now, though, the body says the product is in the clear.
After examining the five fatalities and relevant post-marketing safety data, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the info it has doesn’t “suggest any increase in mortality with Uptravi, and the death rate in patients taking Uptravi is in line with observations for other PAH medicines.”
It’ll keep an eye on things, of course, and “emerging data from ongoing and planned studies will be carefully evaluated as they become available,” the EMA said in a statement. But for now, “no specific regulatory action is considered necessary,” and both new and existing patients can freely use the product.
It’s good news for Johnson & Johnson, which earlier this year inked a $30 billion pact for Actelion’s marketed meds that’s slated to close in Q2. Indicated for patients in the intermediate stages of PAH, Uptravi plays a key role in the Swiss biotech’s portfolio, bridging the treatment gap between baseline therapy Opsumit and late-stage treatment Veletri.
Uptravi—which bears a hefty $160,000 price tag—is also helping make up for declining sales of aging PAH standout Tracleer. The pair of Uptravi and Tracleer follow-up Opsumit combined for CHF 1.07 billion in 2016 sales, more than enough to make up for the elder med’s slide.