Safety concerns prompt Multaq restrictions
pharmafile | September 26, 2011 | News story | Sales and Marketing | Multaq
The European Medicines Agency has recommended Sanofi’s Multaq be restricted due to ongoing concerns about its safety profile.
The drug is currently licensed to treat adults who have had atrial fibrillation in the past, or who currently have non-permanent atrial fibrillation.
But the Agency is now saying that treatment with Multaq should be restricted to patients with paroxysmal or persistent atrial fibrillation when sinus rhythm has been obtained.
The Agency is also recommending Multaq (dronedarone) should now only be prescribed after alternative treatments have been considered, including the older generic medicine amiodarone, which Multaq was looking to replace.
The Agency added that patients who are currently taking Multaq should have their treatment evaluated by their doctor at their next scheduled appointment.
The EMA has taken the decision after increased risks of liver and lung adverse events were seen during a recent review by the CHMP.
The Agency was also concerned after the recent PALLAS study, which was designed to investigate the use of Multaq compared to placebo in patients over 65 years of age with permanent atrial fibrillation and several risk factors, was stopped early due to a series of cardiovascular deaths in the study.
“Although Multaq has not been approved for this patient population,” the Agency said, “[We were] concerned about the outcome of the PALLAS study and extended its review to also look at the data relating to cardiovascular safety of the medicine as well as other data that became available on the risk of damage to the lungs.”
Multaq still an important drug for some patients
The EMA did say, however, that Sanofi’s drug was still an important treatment for some patients with non-permanent atrial fibrillation.
The CHMP was of the opinion that the benefits of Multaq outweighed its risks in these patients, provided that further changes to the information for prescribers and patients is introduced to minimise the risk of injury to the liver, lung and heart.
Sanofi focused on this aspect of the EMA’s decision, and its chief medical officer Dr Jean-Pierre Lehner, said: “The CHMP opinion is significant as it ensures availability of an important treatment option for paroxysmal and persistent atrial fibrillation, a growing public health concern associated with life threatening consequences.”
Multaq failed to take off as analysts predicted, and brought in just 131 million euros in the first half of this year, despite being on the market since 2009 and being touted as a future blockbuster.
The EMA’s position will only further damage its trajectory, as could a similar review of the drug by the FDA, which is expected by the end of the year.
Ben Adams
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