Bayer/Johnson & Johnson’s new oral anticoagulant rivaroxaban has moved closer to gaining approval after advisors to the European regulator recommended its use.

The Committee for Medicinal Products in Human Use says that rivaroxaban, which is partnered with Johnson & Johnson and will be sold as Xarelto, should be approved for the prevention of venous blood clots in patients undergoing planned hip or knee replacement surgery. The recommendation is based on the RECORD clinical programme that included three Phase III trials of rivaroxaban involving 10,000 patients which demonstrated its superior efficacy in head-to-head comparisons with the current gold standard treatment, Sanofi-Aventis’ Lovenox (enoxaparin). The three trials also showed that Xarelto and Lovenox had comparable safety profiles including similar low rates of major bleeding.

Kemal Malik, member of the Bayer HealthCare Executive Committee, responsible for product development, noted that the recommendation for approval of rivaroxaban by the CHMP is a “significant milestone”. He added that “we received it only nine months after the submission – very fast compared to average”.
Full approval from the European Medicines Agency and European Commission typically takes three months so Xarelto, a single pill taken once-daily, should be available before the end of the year.

Bayer has filed rivaroxaban in more than 10 other countries, including Canada and China and a submission for regulatory approval in the USA will be made shortly. J&J unit Ortho-McNeil will sell the drug there and pay the Leverkusen-based firm royalties. The firm expects to generate up to 2 billion euros in annual revenues from Xarelto, though most of that would come from using the drug for stroke prevention in patients with atrial fibrillation. Bayer hopes to win approval for that indication in 2011.

However in its battle to take market share from Lovenox, Bayer will also need to make up ground on Boehringer Ingelheim’s oral anticoagulant Pradaxa (dabigatran), which was launched in the UK in April.

Bayer has received some additional good news on the regulatory front, this time for its other potential blockbuster Nexavar (sorafenib). The State Food and Drug Administration of China has approved the drug for the treatment of unresectable or metastatic hepatocellular carcinoma, based on two international Phase III trials that evaluated more than 800 patients who received no prior systemic therapy.

Gunnar Riemann, member of the executive committee of Bayer HealthCare, said that China has the highest number of liver cancer patients worldwide “with more than 340,000 new cases diagnosed each year and the incidence is continuing to rise".