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

The FDA had asked for additional analyses of the data, Ware said, although he declined to specify the information that the agency requested. "There's been nothing that's stumped us," he asserted.

The prasugrel application is the largest in Lilly's history, Ware said. "They certainly have a lot to review in a short period of time," he said.

This optimism was shared by many industry experts who pointed out that the companies have neither been requested for additional data nor asked to attend an advisory panel meeting, precursors to usual delays or rejections. They consider the current delay to the large volume of data submitted by the two companies and the problems of an understaffed FDA.

The study submitted to the FDA, funded by Daiichi and Lilly, involved 13,608 patients followed for a little over a year in 30 countries.

In the study, prasugrel prevented more heart attacks and strokes than Plavix, an $8.1 billion seller last year. However, more people taking prasugrel died from bleeding than those taking Plavix in the trial.

Lilly and Daiichi Sankyo have started another study called Trilogy, involving 10,000 patients in 35 countries. The study will test whether prasugrel is better than Plavix in patients being treated for acute coronary syndrome, a group of common heart conditions including chest pain and heart attacks.

If approved, prasugrel will be marketed as Effient, and is expected to have a market of $750 million in 2011 and $950 million by 2015. A three-month delay can potentially cost $15 million.

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