Global Insight Perspective | |
Significance | A head-to-head Phase III study shows the superior efficacy of U.S. Eli Lilly/Japanese Daiichi Sankyo's drug prasugrel compared to U.S. Bristol-Myers Squibb (BMS)'s top-selling anticoagulant clopidogrel. |
Implications | Clopidogrel is the generic name of BMS's blockbuster drug Plavix, and prasugrel's clinical profile is an important element on its way to market approval. |
Outlook | The U.S. FDA has until 26 September 2008 to give its verdict on prasugrel, and the study results are hoped to strengthen prasugrel's chances of approval. |
Eli Lilly/ Daiichi Sankyo's Prasugrel Gains Edge over Clopidogrel in New Head-to-Head Study
A new Phase III head-to-head study has revealed that patients with acute coronary syndromes (ACS) managed with an artery-opening procedure (percutaneous coronary intervention) event taking U.S. Eli Lilly and Japanese Daiichi Sankyo's experimental drug, prasugrel,
had 35% less chance of a recurrent event than those taking clopidogrel, the two companies announced in a joint press release. The study enrolled a total of 13,608 patients at 707 trial sites across 30 countries.
Clopidogrel the generic name of Plavix, U.S. major Bristol-Myers Squibb (BMS)'s best-selling drug that garnered in excess of US$4.7 billion in 2007 (see United States: 1 February 2008: Streamlining Strategy Shows Results as BMS Cuts Net Loss 33.5% Y/Y in Q4).
The primary measure of the head-to-head study (TRITON-TIMI 38 trial) showed that when prasugrel was taken with aspirin, the risk of a recurring event was reduced by 19% more than clopidogrel and aspirin. Prasugrel's benefits were accompanied by an increased risk of bleeding, some of which may be life-threatening.
Elliott Antman, M.D., director of the Samuel A. Levine Cardiac Unit at Brigham and Women's Hospital in Boston (U.S.) and principal investigator in the study said, "Not only do multiple heart events increase healthcare costs due to additional hospitalisations, tests and physicians visits, but they also result in higher morbidity for many patients", notes the source.
Outlook and Implications
The results from the head-to-head study are expected to strengthen prasugrel's position on the market, once the drug is approved.
At present, the U.S. FDA has extended the review period for prasugrel by three months, with the revised FDA action date for prasugrel set for 26 September. This was done, according to FDA, in order to give the regulator more time to consider supplemental information provided during the review period (see United States: 24 June 2008: U.S. FDA Extends Prasugrel Review Period by Three Months).
The New Drug Application (NDA) for prasugrel had been submitted on 26 December, with Daiichi-Sankyo and partner Eli Lilly seeking an indication for prasugrel for the treatment of patients with acute coronary syndromes (ACS) being managed with percutaneous coronary intervention (PCI).
The latest clinical results are very good news for prasugrel, giving it a competitive edge once the drug enters the market. Plavix is by far BMS's most dominant product by net sales; U.S. net sales for Plavix in 2007 stood at US$4.1 billion, but its patent is due to expire in 2011, opening the door to cheaper generic versions. Under such circumstances, a superior efficacy profile will be the selling point for prasugrel not only against the original Plavix, but more importantly over cheaper generic versions of clopidogrel.