US FDA delays approval on new drug by Eli Lilly and Daiichi Sankyo

25 June 2008

US regulators have extended the review period for Eli Lilly and Co and Daiichi Sankyo's new blood-thinning drug prasugrel, delaying a decision on approval by three months. The Food and Drug Administration (FDA) extended the review period of prasugrel until 26 September as it considers supplemental information, the two companies said in a statement on Monday.

The product, a rival to Plavix from Sanofi-Aventis and Bristol-Myers Squibb, is vital to Indianapolis-based Lilly's plan to replace lost revenue when its top-seller, the antipsychotic Zyprexa, faces generic competition in 2011. Daiichi has also expanded its reach in the generics space with its recent acquisition of India's biggest drugmaker Ranbaxy.

The companies had submitted their application to the FDA on 26 December last year. The application was reviewed on a priority basis, which shortens the review time to six months from the typical 10 to 12 months.

Although Daiichi shares fell on the news, those of its competitors Sanofi-Aventis and Bristol-Myers Squibb, rose. Daiichi fell 65 yen, or 2.3 per cent, to 2,770 yen on the Tokyo Stock Exchange today, the lowest since 13 May Ube Industries Ltd., a Daiichi Sankyo supplier, fell 2.5 per cent to 348 yen. In contrast, shares in Sanofi-Aventis rose 1.7 per cent in early trade.

''We remain confident in our prasugrel submission package,'' said Jennifer Stotka, vice president for Global Regulatory Affairs at Lilly, in a statement. ''We will continue to work closely with the FDA throughout the review process.''

Dr. Anthony Ware, a Lilly vice president who leads cardiovascular and acute care development, said the companies remained confident in the overall submission package.