Boehringer Ingelheim’s anti-clotting pill ready for launch
pharmafile | February 15, 2008 | News story | Research and Development |Â Â Â
Boehringer Ingelheim's Pradaxa is expected to gain final regulatory approval shortly and could make a major impact in the anti-thrombosis market.
Pradaxa (dabigatran) is a pill and as such could provide a convenient alternative to warfarin (which requires close monitoring) and to Clexane, Sanofi-Aventis' once-daily injection.
Boehringer Ingelheim's head of R&D Dr Andreas Barner said: "This announcement represents a major milestone in the advancement of anti-coagulation therapy for thromboembolic disease."
CHMP approval for the drug means final EU clearance could come as early as April, giving it a few months lead over a rival drug, Bayer's Xarelto.
Both products are novel oral drugs seeking a licence to treat post-surgery venous thromboembolism (VTE). The condition is the most frequent complication following major orthopaedic surgery and is potentially fatal. It begins with a blood clot in a vein and patients having major orthopaedic surgery are at particularly high risk because large leg veins that carry blood to the heart are frequently damaged during surgery, significantly increasing the risk of coagulation and thrombosis.
The current standard treatment is Sanofi-Aventis' Clexane (enoxaparin), which is given as a once-daily injection.
In trials Pradaxa was shown to be as effective and safe as Clexane in preventing VTE and all cause mortality following total hip and total knee replacement surgeries.
Both Pradaxa and Xarelto are predicted to become blockbusters earning in excess of $1billion annually, but just how much they will earn will depend on the number of indications they can gain, and in convincing doctors they are safe.
Drug safety is a key issue in the field after the 2006 withdrawal of AstraZeneca's VTE treatment Exanta (ximelagatran) due to concerns over its liver side effects.
Exanta was a first-in-class direct thrombin inhibitor, the same class as Pradexa and Boehringer is widely studying its drug's safety.
Its clinical trial programme involves more than 34,000 patients worldwide. An independent committee has frequently monitored patients' liver enzyme elevations in all its phase III trials, and suggests very few patients suffered worrying elevations while on its drug.
Pradaxa is also being studied for prevention of stroke and systemic embolism in patients with atrial fibrillation, or irregular heartbeat. It has enrolled over 18,000 patients into its RE-LY trial – the largest conducted to date in the area – which compares Pradaxa to current standard treatment warfarin.
Dr Barner said: "[Pradaxa] is the most advanced novel oral anticoagulant in clinical development and we are confident it will fulfill the unmet medical need for a safe and effective oral treatment for the prevention of thrombotic events in a variety of different clinical conditions."
Boehringer Ingelheim will need to undertake a major medical education and PR programme to introduce its new product to doctors, and the company has signed up Chandler Chicco Agency for European PR support, beginning with a pre-launch promotional programme.
