Posted By Jacob Goldstein On February 23, 2009 @ 8:47 am In
Once again, a drug has won approval in Europe before the U.S. This time, it’s the anticlotting drug prasugrel from Eli Lilly and Daiichi Sankyo. The companies said today that the drug has been greenlighted in Europe for certain patients who have stents put in to clear the arteries around the heart.
The drug, marketed under the name Efient, will compete with the blockbuster Plavix, which is co-marketed by Bristol-Myers Squibb and Sanofi-Aventis.
As we noted a few weeks back when J&J’s Stelara for psoriasis was approved in Europe, it’s become pretty common for drugs to make it to market in Europe before the U.S.
The FDA typically comes to the same conclusions as its European counterparts, but not always. Galvus, Novartis’s diabetes drug, was approved in Europe but has stalled here. And Sanofi’s weight-loss drug Acomplia, which never made it to the U.S. market, was approved in Europe but later suspended over concerns connected to psychiatric side effects.
Still, the U.S. prospects for prasugrel look good. A committee of FDA advisers recently voted unanimously in favor of approving the drug.
WASHINGTON, Feb 26 (Reuters) - Congressional investigators are probing the U.S. Food and Drug Administration's decision to remove a scientist from an advisory panel that reviewed Eli Lilly and Co (LLY.N: Quote, Profile, Research, Stock Buzz) and Daiichi Sankyo's (4568.T: Quote, Profile, Research, Stock Buzz) proposed blood thinner prasugrel, a spokesman told Reuters on Thursday.
The FDA pulled prominent cardiologist Dr. Sanjay Kaul from the panel after Eli Lilly contacted the agency about his publications and media interviews, which cite concerns about the drug's safety.
Lawmakers are concerned the FDA may have been swayed by the drugmaker and acted in the companies' interests rather than for the public good.
The U.S. House Representatives Energy and Commerce Subcommittee on Oversight and Investigations plans to send letters of inquiry to both the FDA and Eli Lilly within days, the subcommittee's spokesman Nick Choate said.
Led by Democrat Rep. Bart Stupak, the subcommittee "is also investigating the issue and will be requesting further information from the FDA and Eli Lilly," he said.
The move comes after another House Democrat, Rep. Maurice Hinchey, in a separate letter earlier on Thursday asked the FDA why it removed Kaul from the panel, which unanimously recommended approval of the drug earlier this month.
Prasugrel, a new blood thinner that would compete with the world's second-best-selling drug, is the most important product in Lilly's pipeline. Company data has shown it prevents more heart complications than its rival, Bristol Myers Squibb Co (BMY.N: Quote, Profile, Research, Stock Buzz) and Sanofi-Aventis SA's (SASY.PA: Quote, Profile, Research, Stock Buzz) (SNY.N: Quote, Profile, Research, Stock Buzz) Plavix, but can also increase the risk of serious bleeding.
Both drugs prevent dangerous blood clots in heart patients.
The fate of Prasugrel is also crucial for Japan's third-largest drugmaker, Daiichi Sankyo, which has boosted its U.S. sales staff by 17 percent ahead of a Prasugrel launch.
Daiichi Sankyo aims to capitalise on the potential blockbuster to shore up earnings amid rising competition, government-mandated price cuts and an economic downturn.
The lawmakers' probe comes a day after the FDA said it would stop processing some drug applications from India's generic drug maker Ranbaxy Laboratories (RANB.BO: Quote, Profile, Research, Stock Buzz), a Daiichi Sankyo subsidiary, alleging data falsification. [ID:nN25490477]
Daiichi Sankyo has reported its first-ever quarterly loss on the sharp devaluation of its stake in Ranbaxy amid FDA investigations into the alleged data falsifications by Ranbaxy.
Shares of Daiichi Sankyo fell 5.2 percent to 1,593 on Friday, following a 9.5 percent slide on Thursday in the wake of the FDA announcement on Ranbaxy.
"We doubt this will really change the dynamics as the vote would presumably still be 9-1 at worst, but it brings in an element of uncertainty and suggests some weird political game may have been playing out at the FDA," KBC Financial Products analyst Philip Hall said in a note to clients.
Analysts have said that even if Congress investigates, it would only lead to a small delay in the drug's approval. A final FDA decision is pending for prasugrel, which won European approval on Monday under the brand name Efient.
The FDA has acknowledged it removed Kaul because of his comments. Earlier this week, Janet Woodcock, head of the agency's Center for Drug Evaluation and Research, said a series of staff errors prevented the FDA from looking at Kaul's "intellectual bias" until Eli Lilly contacted the agency.
Representatives for Lilly and Daiichi said the companies did contact the FDA about Kaul but that it was up to the agency to decide who served on its advisory panels.
"This situation does not instill policymakers with confidence that the FDA is capable of objectively overseeing the drug industry," Hinchey wrote in his letter to the FDA.
Kaul, who works at Cedars Sinai Medical Center in Los Angeles, could not be reached for comment.
It was not immediately clear if the letters would lead to hearings or other congressional action.
The FDA often looks to its panels of outside experts for advice about experimental therapies before making approval decisions and usually follows their recommendations. It regularly bars those who have financial conflicts of interests, but critics have chided the agency for removing Kaul over his comments.
Last week, advocacy group Public Citizen Health Research Group called on the FDA to clarify its policy on bias. "The case of Dr. Kaul creates the appearance of a lack of such a policy, or the flawed execution of one if it exists," it said in a letter to the agency.
The group also urged a boxed warning for the drug if it gets approved as well as further studies.
On Feb. 3, the FDA's advisory panel voted 9-0 in favor of approving prasugrel, saying it could offer an alternative for some patients and that its benefits justified the additional bleeding risk in certain cases.
Woodcock, talking to reporters on Monday, blamed low-level officials for not properly screening Kaul's paperwork or talking to their superiors before allowing him on the panel in the first place.
"At every step of the way some error was made," she said, adding the agency has put new procedures in place.
"We feel we had nine extremely competent individuals who were able to give us advice," she said. "Dr. Kaul was not included among the advisers at this meeting but we don't believe that invalidates the results of the panel."
But another FDA official said Kaul should have been included, despite his comments.
"In my own personal opinion, I didn't see anything in those writings or in those statements that would preclude him from serving as a member of the committee ... I think he would have been a very valuable member of the committee," John Jenkins, head of the FDA's office of new drugs, said.
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