Plavix receives further sNDA approval in Japan

French drug major Sanofi-Aventis says that the Japanese Ministry of Health, Labor and Welfare has granted approval for a supplemental New Drug Application for "acute coronary syndrome (unstable angina pectoris, non-ST elevation myocardial infarction) for which percutaneous coronary intervention is being planned for Plavix (clopidogrel)," its blockbuster anti-platelet drug co-marketed with US major Bristol-Myers Squibb.

According to Sanofi-Avantis, approximately 100,000 patients develop an acute coronary syndrome and elect to undergo PCI every year in Japan, where Plavix is now the first drug approved in this indication, the largest number of patients in the world outside of the USA. On the day of the news, October 19, the firm's US shares fell 1.6% to $42.31. In Japan, this new cardiology extension completes the May 2006 approval for the agent in the reduction of recurrence of stroke for which the two weeks-prescription-only-limitation has been lifted in May 2007, as result of a favorable one-year safety assessment.

The French drug major noted that the efficacy and safety profile of Plavix is well established in multiple large-scale Japanese and international landmark trials involving more than 100,000 patients, as well as from real-life clinical experience in over 70 million patients worldwide including Japan. The guidelines suggest that Plavix can fill an important medical need for patients with UA-NSTEMI, the French firm noted.