FDA advisory committee recommends approval for Takeda’s vedolizumab
DEERFIELD, Ill. — An expert panel at the Food and Drug Administration has given a thumbs-up to an experimental drug made by Takeda Pharmaceutical Co. for treating ulcerative colitis and Crohn’s disease, the drug maker said.
Takeda said the FDA’s Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committee voted in favor of approval for vedolizumab in adults with moderately to severely active UC or Crohn’s. A favorable advisory committee vote does not guarantee FDA approval of a drug, but the agency usually follows the votes when deciding whether or not to grant approval.
"People with ulcerative colitis or Crohn’s disease are in need of additional treatment options, as many patients lose response to currently available treatments," Takeda VP general medicine Asit Parikh said. "Vedolizumab was designed to treat inflammation of the [gastrointestinal] tract and, if approved, may offer an additional option for patients suffering from ulcerative colitis or Crohn’s disease."
Study: Despite understanding flu’s seriousness, misconceptions remain
BETHESDA, Md. — Only a quarter of respondents to a new survey would call a doctor for advice when someone at home has the flu, despite widespread recognition of it as serious and of the need for vaccination.
The study, conducted by the National Foundation of Infectious Diseases, found that 93% of adults understand the flu is serious, while 87% understand it’s highly contagious, and 66% understand the need for vaccination. The study included a national survey of 1,000 adults and surveys of 500 adults in 10 states, collected between Aug. 6 and Aug. 28.
"It is reassuring that individuals recognize the importance of receiving an annual vaccination, but that’s not enough," NFID medical director Susan Rehm said. "To help keep influenza out of homes, schools and workplaces, everyone needs to get vaccinated and know to contact a doctor at the first sign of flu symptoms."
But there was confusion about when it was contagious and how to treat it. For example, 44% of respondents thought they could treat it with antibiotics, while 48% thought the flu vaccine would treat it. Meanwhile, 41% didn’t know it’s contagious before symptoms start, and 59% don’t know there are prescription drugs to treat it.
Experimental AbbVie treatment regimen for hepatitis C produces 96% cure rate
NORTH CHICAGO, Ill. — Nearly all patients taking an experimental treatment for hepatitis C developed by AbbVie were cured, the drug maker said Tuesday.
Announcing results of a phase-3 trial of a regimen consisting of three drugs, plus ribavirin, known as a three direct-acting-antiviral, or 3-D regimen. The trial, called SAPPHIRE-II, included 394 patients. Of those patients, 96% of those who had failed a previous treatment regimen experienced sustained virology response, or SVR, meaning they were essentially cured, after 12 weeks of treatment. A second group of 97 patients was put on placebo during the same period, and then given active treatment for 12 weeks afterward.
The 3-D regimen includes ribavirin, a common generic drug used in hepatitis C, as well as the experimental drugs ABT-450/r, ABT-267 and ABT-333.