EMA green lights Actelion’s drug after patient deaths scare

The EMA has ruled that the five patient deaths that occurred in February of this year were not directly related to Actelion’s Uptravi and it was therefore cleared for use. The patient deaths happened in France and were in patients who were receiving Uptravi for treatment of pulmonary arterial hypertension.

The news will come as a relief to Johnson & Johnson which announced that it had agreed a deal to takeover Actelion at the beginning of the year. The EMA had advised doctors to follow closely the prescribing information for Uptravi after learning of the deaths. After careful investigation of the deaths and the data available, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) came to the conclusion that were no additional safety risks associated with the drug.

The EMA released a statement regarding its findings: "EMA’s PRAC closely examined the 5 fatal cases. In addition, the PRAC studied relevant safety data that have been collected since the medicine started to be marketed, as well as data from clinical trials and comparisons with data from other PAH medicines. The PRAC concluded that the data examined do not suggest any increase in mortality with Uptravi, and the death rate in patients taking Uptravi is in line with observations for other PAH medicines."

The EMA did note that it would continue to monitor the safety of Uptravi, as well as keeping tabs on data from clinical trials.

Uptravi has a price tag of $160,000 and has been approved for close to year. Its sales have proved important to the business and J&J will expect to see those sales continue, as Jean-Paul Clozel, found of Actelion, professed that he expected sales to continue to grow over the years.