European OK for Pradaxa, but more details required
pharmafile | May 29, 2012 | News story | Research and Development, Sales and Marketing | Boehringer, CHMP, EMA, Europe, Pradaxa
The European Medicines Agency says that Boehringher’s Pradaxa can stay on the market, but will need more safety information.
The Agency has been looking into post-marketing studies of the drug after high rates of bleeding were seen in some Phase III clinical trials.
Bleeding is a well-known complication of all anticoagulant medicines, and Pradaxa has been kept under close review by the Agency’s Committee for Medicinal Products for Human Use (CHMP) since its approval last year.
The CHMP, a committee of experts working with the EMA, concluded that the benefits of Pradaxa continue to outweigh its risks and that it remains “an important alternative to other blood-thinning agents”.
They also found that the frequency of occurrence of fatal bleedings with Pradaxa seen in post-marketing data was significantly lower than that observed in the clinical trials that supported the drug’s approval.
“However, the advice to doctors and patients should be updated and strengthened to give clearer guidance on the best use of the medicine,” they said.
This includes more specific guidance on when Pradaxa must not be used, as well as advice on managing patients and reversing the anticoagulant effect of Pradaxa if bleeding occurs.
The Agency said it has produced a question-and-answer document for patients and healthcare professionals that provides more detailed information on the Committee’s recommendations.
The final decision on whether to implement these new proposals rests with the European Commission, which will announce its verdict later this year.
This is not the first safety concern surrounding Pradaxa – in October last year the EMA told Boehringer it must alert doctors to check their patient’s kidney functions prior to using the drug.
This is because Pradaxa is mainly excreted renally, meaning that the treatment should not be prescribed to patients with severe renal impairment.
There were more serious concerns when in November last year Boehringer said that 260 cases of fatal bleeding have been linked to Pradaxa in post-marketing studies.
But it added that this was still below the rate that emerged in its Phase III trial that led to the drug’s approval, and said that the drug’s benefits still outweighed its risks.
Blockbuster sales
Pradaxa, which made $1 billion in sales last year, is one of three new oral anticoagulants looking to replace the 50-year old treatment warfarin.
Bayer’s Xarelto and Pfizer/BMS’ Eliquis are also licensed – or seeking licences – for a number of indications, with stroke prevention in patients with atrial fibrillation seen to be the most lucrative.
Both Pradaxa and Xarelto already have this license in Europe, but the EMA is still to decide whether Eliquis should gain this indication.
Ben Adams
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