Rivaroxaban Okayed for PE in Europe


October 19, 2012

October 19, 2012 (London, United Kingdom) — The European Union's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on approval of rivaroxaban (Xarelto, Bayer) at the 15-mg and 20-mg doses for the additional indication of treatment of pulmonary embolism (PE) and prevention of recurrent pulmonary embolism in adults [1].

The factor Xa oral anticoagulant is already available in Europe for the prevention of nonvalvular AF-related stroke and systemic embolism and for the treatment and prevention of deep venous thrombosis (DVT).

Also at its meeting on October 18, the CHMP added some new contraindications for rivaroxaban as follows:

Lesion or condition at significant risk of major bleeding such as current or recent gastrointestinal ulceration; presence of malignant neoplasms at high risk of bleeding; recent brain or spinal injury; recent brain, spinal, or ophthalmic surgery; recent intracranial hemorrhage; known or suspected esophageal varices; arteriovenous malformations; vascular aneurysms; or major intraspinal or intracerebral vascular abnormalities.

Concomitant treatment with any other anticoagulant agent--eg, unfractionated heparin (UFH), low-molecular-weight heparins, heparin derivatives (fondaparinux), oral anticoagulants (warfarin, apixaban, dabigatran, etc)--except under the circumstances of switching therapy to or from rivaroxaban or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter.

These recommendations now await final approval by the European Commission.

Phentermine/Topiramate Combination Refused

The CHMP also adopted a negative opinion, recommending against approval of the combination phentermine/topiramate product (Qsiva, Vivus BV) for the treatment of severe obesity [2].

While the committee agreed that studies with the product had shown clinically relevant weight loss, it was concerned about long-term effects on the heart and blood vessels, particularly due to the effects of phentermine, which is known to increase the heart rate but whose long-term effects are not clear. There were also concerns about the long-term psychiatric effects (depression and anxiety) and cognitive effects (problems with memory and attention) related to the topiramate component, which is also thought to be potentially harmful to the unborn baby if taken by pregnant women.

In addition, the committee noted that there was a high probability that, if approved, the medicine would not be used strictly for the intended patients.

By comparison, the drug, known in the US as Qsymia (formerly Qnexa), was granted FDA approval for weight loss this summer but accompanied by a risk evaluation and mitigation strategy (REMS).