EMA examines key Actelion med Uptravi following 5 patient deaths in France

Actelion
The EMA is reviewing Actelion's Uptravi following five patient deaths in France.

Johnson & Johnson is counting on new buy Actelion’s pulmonary arterial hypertension (PAH) meds to provide a top-line boost once its $30 billion transaction closes. But one of them may have just hit a safety snag.

The European Medicines Agency is taking a hard look at the safety of new product Uptravi after five patient deaths in France, the regulatory body said in a statement. For now, both existing and new patients can take the drug, provided they use it in line with current prescribing info, the EMA said, and the body will publish its findings once its wraps its review.

Uptravi is a key part of Actelion’s portfolio. Launched last January—with a $160,000 price tag—the med competes for patients in the intermediate stages of PAH, creating a bridge between baseline therapy Opsumit and late-stage treatment Veletri.

It’s also helping fill the void left by aging PAH superstar Tracleer; in 2016, it raked in CHF 245 million ($243 million) for the Swiss drugmaker, which—combined with Opsumit’s CHF 831 million haul—more than made up for Tracleer’s declines.

And J&J, for its part, thinks it’ll be able to get even more out of the product—provided, of course, that the safety hurdles don’t get in the way. The New Jersey pharma giant plans to use its global footprint and “world-class customer-facing capabilities to deliver new commercial opportunities,” company pharma chairman Joaquin Duato told investors on a conference call last month.

J&J’s top line could certainly use the help. Key meds, including cancer star Imbruvica, disappointed in Q4, dragging the company’s revenue numbers below Wall Street forecasts.

Actelion, meanwhile, has already suffered one setback since J&J got interested. Late last month, it announced that Opsumit had flopped a phase 3 trial aimed at expanding the med's market, although analysts were generally nonplussed by the news.