In a final appraisal determination, the National Institute of Health and Clinical Excellence recommended Eli Lilly and Daiichi Sankyo’s Efient (prasugrel) for use on the NHS as a treatment to prevent atherothrombotic events in certain high-risk patients with acute coronary syndromes undergoing percutaneous coronary intervention (PCI).

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NICE stated that the antiplatelet agent, in combination with aspirin, should only be used when immediate primary PCI for myocardial infarction is necessary, stent thrombosis has occurred during treatment with sanofi-aventis and Bristol-Myers Squibb’s Plavix (clopidogrel), or if the patient has diabetes.

Efient was launched in the UK earlier this year.

Source: FirstWord

Popularity: 3% [?]

The combined use of proton pump inhibitors (PPIs) with sanofi-aventis and Bristol-Myers Squibb’s Plavix (clopidogrel), or with Eli Lilly and Daiichi Sankyo’s Effient (prasugrel), did not interfere with the clinical benefits of the antiplatelet agents in patients after an acute coronary syndrome (ACS), according to an analysis of study data to be published in The Lancet. Researchers noted that the results contrast with prior findings from other studies, and remarked that these latest data “do not support the need to avoid concomitant use of PPIs…in patients receiving clopidogrel or prasugrel.”

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The analysis was based on data from the randomised TRITON-TIMI 38 trial that enrolled over 13 600 patients who suffered a heart attack or unstable angina, and who were given either Plavix or Effient. The study authors evaluated the effects of PPIs in the trial, and they found that for patients who took these medications in combination with Plavix or Effient there was no increased risk of cardiovascular events, compared with patients who took Plavix or Effient alone.

A previous analysis of medical and pharmacy claims data by Medco indicated that among patients who had undergone a percutaneous coronary intervention, those who were being treated with Plavix plus a PPI had a 50-percent increase in the risk of having a major cardiovascular event, compared with those who took Plavix alone.

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The author of the Medco study, Robert Epstein, explained that the overall health of the patients involved in the studies may have played a role in producing contrasting results. He suggested that the new analysis involved healthier patients who were not in a “real-world setting.” The lead investigator of the latest study, Michelle O’Donoghue, noted that PPIs are often given to more seriously ill patients, which might explain why they experience more adverse events. However, she said such differences were adjusted for in the research. The authors stated that a thorough clinical trial is needed to clearly understand how PPI use affects treatment with antiplatelet drugs.

Source: FirstWord

Popularity: 3% [?]

The FDA announced that it approved Eli Lilly and Daiichi Sankyo’s antiplatelet agent Effient (prasugrel) to reduce the risk of blood clots from forming in patients who undergo angioplasty. The agency also noted that the product’s label will include a boxed warning to advise of the potential for “significant, sometimes fatal, bleeding.” The companies indicated that they expect to launch Effient in the US in the coming weeks.

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Data from a trial involving over 13 600 patients compared Effient to sanofi-aventis’ and Bristol-Myers Squibb’s Plavix (clopidogrel) in patients with a threatened heart attack or an actual heart attack who were about to undergo angioplasty, the US regulator stated. Results showed that the fraction of patients who had subsequent non-fatal heart attacks was reduced from 9.1 percent in the Plavix arm to 7 percent in those who took Effient. A greater risk of significant bleeding was observed in patients taking Eli Lilly’s and Daiichi Sankyo’s drug.

The boxed warning will advise that Effient should not be used in patients “with active pathological bleeding, a history of transient ischemic attacks or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.” Spokeswoman Laura Hortas of Bristol-Myers Squibb indicated that Effient is approved only for a portion of the patient population for which Plavix is approved.

Commenting on the warning label for Effient, analyst Les Funtleyder of Miller Tabak & Co. noted that “the FDA has been a lot more liberal with black-box warnings than it was in the past, and in a way the black box has lost some of the meaning it had when it was rare…But it still has the ability to somewhat limit sales.” Deutsche Bank analyst Barbara Ryan added: “I think it will make it tough for [Effient] to compete against Plavix.” She remarked that her previous projection for peak annual sales of $1 billion for Effient might be too high. Meanwhile, Caris & Company analyst David Moskowitz speculated that Eli Lilly’s and Daiichi Sankyo’s product will have revenue of $500 million by 2013 and will probably hold up to 25 percent of the market at its peak. He explained that “it’s going to take time for them to penetrate the market with this label.”

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In response to the concerns, Anthony Ware, a vice president in Eli Lilly’s research business, said he didn’t think the boxed warning would be a significant detriment to the marketing of Effient. “We think it’s important to let patients and the physician know about the bleeding risks, which can sometimes be serious…and to be able to balance that with efficacy,” he stated.

The antiplatelet agent was launched in April in Europe, where it is sold as Efient.

Source: FirstWord

Popularity: 4% [?]

A consumer advocacy group and a patent holder on Eli Lilly’s and Daiichi Sankyo’s Effient (prasugrel) urged the US regulator to halt its review of the antiplatelet agent, arguing that available evidence raises questions about the compound’s safety and efficacy at the proposed daily dose. In a letter addressed to FDA Commissioner Margaret Hamburg on Wednesday, the authors said the drug should not be considered for approval “until a new Phase III study can be conducted with an appropriate lower dose of prasugrel and properly defined outcomes.”

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In the letter, Effient patent application holder Victor Serebruany and Public Citizen’s Sidney Wolfe and James Floyd suggested there were “serious flaws” in the late-stage TRITON-TIMI 38 trial, which compared Effient to sanofi-aventis’ and Bristol-Myers Squibb’s Plavix (clopidogrel) in patients with acute coronary syndrome. The study, from which data were submitted to support the FDA filing of Effient, “did not offer a ‘fair’ comparison of prasugrel and clopidogrel, both because of the dose selection and the timing of the loading dose,” the authors stated. They also indicated that the benefit of the antiplatelet agent in reducing heart attacks “was driven by nonfatal myocardial infarction, the definition of which changed several times during development of the drug.”

Regarding the safety of Effient, the authors concluded that the daily 10-milligram dose is unsafe due to data that show an increased risk of excess haemorrhage observed in patients taking the drug, and they also noted “an excess of new cancers, especially highly metastatic solid tumours” in the group.

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In February, an FDA advisory panel recommended Effient for approval to treat patients with acute coronary syndromes being managed with percutaneous coronary intervention. FDA staff reviewers had concluded prior to the advisory meeting that the drug’s benefits outweighed its risks. Eli Lilly has indicated that tests are underway on a lower dose of the drug, but the study won’t be completed until 2011.

Source: FirstWord

Popularity: 4% [?]

A device to repair damaged knees lands on the front page of this morning’s WSJ, in a story that details all the behind-the-scenes lobbying that can go on between industry and the FDA.

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There are lots of elements to the story, but one caught our eye: At one point, the FDA set up a special committee of outside experts to hash out key questions related to the device, called Menaflex.

The doc who chaired the committee told the WSJ that “In retrospect, I think they [the FDA] were stacking the committee to get the decision the company wanted.”

The head of the agency’s device decision says he followed normal procedures in approving the device and didn’t let pressure from the company affect his decision. Officials from the company, ReGen Biologics, say the device is safe and can benefit patients.

Just last month, there were questions about another FDA committee of outside experts — the one that reviewed Eli Lilly’s anti-clotting drug prasugrel. Some experts were surprised that the FDA didn’t invite members of its safety and risk-management committee to weigh in on the drug.

And the FDA barred a cardiologist who had been critical of prasugrel from sitting on the committee — a decision the agency later said was a mistake. “At every step of the way there were errors by multiple parties,” Janet Woodcock, heads the FDA’s drug division, told Dow Jones Newswires.

The committee voted unanimously in favor of the drug, which was recently approved in Europe.

Source: The Wall Street Journal

Popularity: 2% [?]

US lawmakers asked Eli Lilly CEO John Lechleiter and acting FDA Commissioner Frank Torti to provide documents and communication records regarding a cardiologist that was removed from an FDA advisory panel before it met early in February to discuss the company’s antiplatelet agent Effient (prasugrel), Bloomberg reported.

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Henry Waxman, chairman of the House Energy and Commerce Committee, and Bart Stupak, chairman of the Oversight and Investigation Subcommittee, are seeking information about the removal of Sanjay Kaul of the Cedars-Sinai Medical Center, who had questioned the safety and effectiveness of Effient in articles he had written. The FDA removed Kaul four days before the advisory panel met, citing issues about potential bias after concerns were raised by Eli Lilly over the articles. The panel unanimously recommended approval for Effient, and the FDA later said its decision to remove the cardiologist was a mistake.

Analyst David Moskowitz of Caris & Co. speculated that “the FDA may be instructed to ignore the panel because it wasn’t objective,” and he thinks that the investigation might delay approval and reduce potential sales. The analyst forecasts that Effient, which is being developed with Daiichi Sankyo, may have sales of $1.3 billion in 2014, if approved.

Source: FirstWord

Popularity: 3% [?]

On Monday, Eli Lilly and Daiichi Sankyo announced that the European Commission approved oral antiplatelet agent Efient (prasugrel) to prevent atherothrombotic events in patients with acute coronary syndrome undergoing percutaneous coronary intervention. Eli Lilly spokesperson Carole Copeland indicated the medicine would be introduced to the EU market “in the coming weeks.”

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The approval follows a positive opinion rendered by the European Medicines Agency’s Committee for Medicinal Products for Human Use last December.

Earlier this month, an FDA advisory panel voted unanimously to recommend the drug for approval, which would be marketed as Effient in the US. Copeland did not provide a time frame for US approval, but said “we’re still confident in the submission and working diligently with [the agency] as they continue their review.”

Source: FirstWord

Popularity: 2% [?]

On Thursday, Novartis announced that the company acquired the exclusive worldwide rights to Portola Pharmaceuticals’ anticoagulant elinogrel in a deal that could be worth up to $575 million. The compound, which is in mid-stage testing, has “attributes that have the potential to offer clinical benefits over currently approved antiplatelet therapies,” stated Trevor Mundel, Novartis’ global head of development.

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The Swiss drugmaker noted that data from early trials demonstrated that elinogrel “has an instant onset of action that could quickly provide protection from clotting,” in addition to having an effect that is “reversible.” Joe Jimenez, chief executive of Novartis’ pharmaceutical division, remarked that “the compound appears to be differentiated” from its rivals, such as sanofi-aventis and Bristol-Myers Squibb’s Plavix (clopidogrel). Moreover, Portola CEO Charles Homcy suggested that Eli Lilly and Daiichi Sankyo’s antiplatelet agent Effient (prasugrel), which an FDA advisory panel recommended for approval earlier this month, also has some of the same drawbacks associated with Plavix.

Elinogrel, which is being developed in oral and intravenous formulations, is currently in a head-to-head trial against Plavix in patients undergoing non-urgent surgery to repair a damaged blood vessel or to unblock a coronary artery. A Phase III trial of the compound is slated to begin in 2010.

As part of the agreement, Novartis will make an upfront payment of $75 million to Portola to license the candidate, and will make additional payments of up to $500 million if certain development and commercial milestones are reached. Portola would also be eligible to receive royalties on future sales.

In related news, Portola’s chief financial officer, Mardi Dier, disclosed that the company was “in discussions with multiple parties” about another of its experimental anticoagulants, betrixaban. Kevin Bottomley of Pharmaventures remarked that “it’s clear why Novartis was interested in [Portola's] lead compound; it’s less clear why they didn’t pick up the second compound.”

Source: FirstWord

Popularity: 4% [?]

An FDA advisory panel voted unanimously on Tuesday in favour of recommending for approval Eli Lilly and Daiichi Sankyo’s Effient (prasugrel) to treat patients with acute coronary syndromes being managed with percutaneous coronary intervention.

Panellists advised against prescribing the antiplatelet agent in patients with a history of strokes and in those undergoing open heart surgery, but did not propose limiting the drug’s use in patients aged 75 and older. The experts also suggested that physicians be advised to use caution in prescribing Effient to older patients and to those who weigh less than 130 pounds because they may experience a higher risk of bleeding.

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Last week, FDA reviewers indicated that the drug’s benefits outweigh its risks. Agency staff also noted higher cancer rates among patients taking the drug, compared to those given sanofi-aventis and Bristol-Myers Squibb’s Plavix (clopidogrel), but suspected that was not due to Effient use. Nevertheless, the FDA indicated that the drug may have to carry warnings about the risk. The agency has yet to set a date for its final decision on the drug.

Commenting on the news, JP Morgan analyst Chris Schott said that “one panel member has already suggested that if there is insufficient proof that prasugrel causes cancer, then having it on the label could cause undue fear or underuse.” Schott also noted that Ellis Unger, the deputy director of the division of cardiovascular and renal drugs products at the FDA’s Center for Drug Evaluation and Research, dismissed concerns Effient may be a cancer risk, saying “does prasugrel cause cancer? Well the short answer is: We don’t think so.”

Schott forecasts the drug will generate sales of $10 million in 2009, if approved, and $825 million by 2013, saying that “you need much clearer side-effect profile and labelling to get the broad adoption you have with Plavix.” Meanwhile, Cowen and Co.’s Steve Scala speculates Effient sales will reach $150 million this year, and increase to $1.5 billion by 2015.

Source: FirstWord

Popularity: 4% [?]

The FDA approved more new drugs in 2008 than in any of the previous three years, The Wall Street Journal reported. The agency approved 24 “first-of-a-kind” drugs last year, compared with 18 in 2007, 22 in 2006 and 20 in 2005, in addition to authorising dozens of other applications for new formulations or new uses for treatments already on the market.

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However, industry observers suggest that 2008 will also be remembered for delays in the approval process, with deadlines missed on 32 out of 159 applications through October 31, according to the agency. Notable delays included Eli Lilly’s and Daiichi’s Sankyo’s experimental oral antiplatelet agent prasugrel, which an FDA advisory panel is now scheduled to review on February 3, and Takeda’s diabetes drug alogliptin. Last week, the Japanese drugmaker said that the FDA will decide on alogliptin by June 26 after failing to meet a prior deadline of October 27 “due to internal resource constraints.”

John Jenkins, director of the agency’s Office of New Drugs, recently said that the FDA has “been struggling to meet [drug approval] goals for the past several years.” However, Jenkins noted that the agency bolstered its drug division last year with the addition of more than 800 employees, adding that the FDA hopes to be closer to its objective of reviewing 90 percent of drug applications on time in 2009.

Source: FirstWord

Popularity: 2% [?]