An FDA advisory panel voted 12-1 recommending the approval of Vertex’s cystic fibrosis drug Orkambi (lumacaftor/ivacaftor). Despite nearly all panel members voting in favor of approval, the committee was divided on whether the research showed any benefit to adding lumacaftor to already-approved treatment Kalydeco (ivacaftor), according to Reuters. The FDA, which is not required to follow the panel’s recommendation, is expected to make a decision on the drug by July 5.
MannKind CFO Matthew Pfeffer said marketing delays are to blame for poor sales of its inhalable insulin, Afrezza. He told in-Pharmatechnologist.com that slow sales are due to a lack of physician awareness about the new drug, saying the company has heard “frequent reports of patients visiting their doctor to ask about Afrezza, only to find their doctors don’t yet know much about it.” While Sanofi is marketing the product, it has yet to begin its DTC campaign—that is expected to kick off in July or August—which Pfeffer believes will help drive demand.
Orexigen Therapeutics is under fire after a postmarketing study evaluating its weight-loss drug Contrave for a cardiovascular outcomes benefit was terminated. The Cleveland Clinic ended the trial, saying an unauthorized release of trial data in March invalidated the study’s results. Orexigen had released 25% of the study’s data two months ago, saying the drug was superior to its placebo group. Data from the next 25% of the study, released Tuesday, told a different story, showing 55 cases of heart attacks, strokes and death in patients taking Contrave, compared to 43 in the placebo group. Takeda, Orexigen’s marketing partner for Contrave, reportedly asked the drugmaker to pay the entire cost of a new cardiovascular outcomes trial, according to Bloomberg Business. Takeda also issued a formal dispute related to the data released in March. Orexigen told Bloomberg that Takeda’s claims are without merit.
People who have been upset w/ Orexigen today:1) the FDA2) their lead investigator3) their big pharma partner4) the market$OREX
— Drew Armstrong (@ArmstrongDrew) May 13, 2015
AstraZeneca further established its position in personalized medicine, signing two deals to explore the promise of personalized treatments for heart disease and respiratory disorders. The British drugmaker inked a deal with Abbott Laboratories to develop a companion diagnostic for an experimental asthma drug and another with Canadian scientists examining the genes associated with heart disease, according to Reuters.
Presidential hopeful Sen. Bernie Sanders (D-Vt.) beseeched the Department of Veteran Affairs to override the patents on AbbVie’s and Gilead Sciences’ pricey HCV drugs. In a letter to the VA Secretary Robert McDonald, he wrote that veterans should not “be denied treatment while drug companies rake in billions of dollars in profits.” He added that there are an estimated 180,000 veterans enrolled in the VA healthcare system who are believed to be infected with the virus.