Bayer and partner Johnson & Johnson will not be responding fully to requests from regulators in the USA for more data about their new anticoagulant Xarelto before the end of the year, as was previously expected.
In May, the US Food and Drug Administration voted 15 to 2 in favour of Xarelto (rivaroxaban) for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery, despite concerns over bleeding and potential liver damage. While the agency said that no new clinical studies are needed as a prerequisite for approval, it has asked for “additional data from completed and ongoing studies of rivaroxaban, and from market surveillance from those countries outside the USA where the drug is currently sold to further assess the risk-benefit profile of the drug”.
The FDA also asked for additional information on the sites where the RECORD study (which forms the basis of the submission) was carried out. That study compared Xarelto with the gold-standard drug, Sanofi-Aventis’ injectable Lovenox (enoxaparin) and in July, Bayer and J&J said they did not expect to submit a reply to the complete response letter from the FDA “until the fourth quarter of this year.
However, the companies now say that following discussions with the FDA, they have decided not to submit their reply by the end of 2009. They claim that “postponing the complete response until these requirements are fully addressed provides the greatest opportunity for successfully bringing rivaroxaban through the regulatory process”. Bayer added that it will “communicate an updated filing strategy” in its annual press conference on February 28.
Visanne approved in EU
Bayer has received more positive news this morning after regulators in Europe gave the go-ahead for Visanne (dienogest) for the chronic gynaecological disease endometriosis. The company noted that the current standard therapy, with gonadotropin-releasing hormone analogues, is only suitable for short-term treatment due to severe side-effects.
Phil Smits, head of Bayer Schering Pharma’s women’s healthcare unit, said that surgical treatment of endometrosis is associated with high relapse rates “and many currently available medical therapy options have side effects which do not allow for long-term use”. There is, therefore, “a high medical need for new treatment options”, he added, noting that market launches of Visanne are planned from the second quarter 2010 onwards.
