FDA approves using Relenza to prevent flu

first_imgMar 29, 2006 (CIDRAP News) – The US Food and Drug Administration (FDA) today approved the use of the antiviral drug zanamivir (Relenza) to prevent—not just treat—influenza in adults and children aged 5 and older.Zanamivir, one of the two flu drugs known as neuraminidase inhibitors, was approved in 1999 for treating flu in people aged 7 and older, but not for prophylactic use. The other neuraminidase inhibitor, oseltamivir (Tamiflu), was approved for both treatment and prevention in adults and children from the age of 1 year.”This approval is a welcome addition to the available defenses against the flu,” Dr. Steven Galson, director of the FDA’s center for Drug Evaluation and Research, said in an FDA news release. “This new use offers the medical community another option to prevent and control influenza A and B.”Many countries are stockpiling oseltamivir, made by Roche, in the hope that it will offer some help in the next flu pandemic. Stockpiling of zanamivir, made by GlaxoSmithKline, has been less prevalent, but the United States is stocking up on both.”We have purchased, as of today, 4 million treatment courses of Relenza and 22 million treatment courses of Tamiflu,” Bill Hall, a spokesman for the Department of Health and Human Services, told CIDRAP News today. “We expect all of them to be in the stockpile by the end of this calendar year.”Hall said HHS is aiming for a total of 81 million treatment courses of the two antivirals by 2008, with zanamivir making probably up about 20%.Zanamivir is a powder that is inhaled by mouth with a “Diskhaler” device. Oseltamivir comes in capsule form.Four large, placebo-controlled studies have shown the effectiveness of Relenza for preventing flu, the FDA reported. In two trials, the incidence of flu in households whose members received the drug was 4.1%, versus 19.0% in households where people received a placebo.In a third trial, involving only adults, 2.0% of people in the Relenza group experienced flu symptoms, versus 6.1% of those in the placebo group, the FDA reported. In the fourth study, which involved mostly older adults, flu symptoms occurred in 1.4% of placebo group members and 0.2% of the treatment group.The FDA said zanamivir has not been found effective for preventing flu in nursing homes. Also, it is not recommended as a substitute for flu vaccine, the primary tool for preventing flu.The drug is not recommended for people who have asthma or other chronic respiratory disease, the FDA noted. After zanamivir’s initial approval, bronchospasm, in some cases fatal, was reported in some patients, most of whom had asthma or chronic obstructive pulmonary disease, the agency said.See also:Mar 29 FDA news releasehttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108622.htmFDA background information on Relenzahttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm183783.htmGlaxoSmithKline’s detailed information on Relenzahttp://us.gsk.com/products/assets/us_relenza.pdfCIDRAP overview on use of antiviral agents for pandemic flulast_img read more

Ireland defeat United States

first_imgIreland overcame a sticky start to beat the United States by 46 runs in Group A of the Twenty20 World Cup qualifiers in Belfast. The visitors’ response was hit by the loss of Akeem Dodson to a duck off the second ball of the innings, while fellow opener Fahad Babar went for 10 as the United States also dropped to 22 for two. Nicholas Standford top-scored for the visitors with 19 but after he fell lbw to George Dockrell the US resistance crumbled and they were all out for 100 runs in the 17th over. Victory leaves the Irish on top of their group with two wins from two games ahead of their third match against Nepal on Monday. The hosts’ hopes of a second straight win appeared to be in jeopardy when openers Niall O’Brien and Paul Stirling fell for seven and eight respectively, leaving them languishing on 22 for two. But a steady 44 by Andy Balbirnie came to Ireland’s rescue and some late fireworks from John Mooney – who hit 20 runs off just seven balls – helped the hosts set a reasonable target of 146. center_img Press Associationlast_img read more

Girls’ soccer: Bucksport defeats Calais; Tigers top DI-S, Narraguagus

first_imgBUCKSPORT — With the high school soccer season heating up, two local girls’ teams have secured vital wins as they push toward the Class C North playoffs.The Bucksport and Sumner girls closed out September by climbing up the standings and inching closer to appearances in the postseason. The Golden Bucks recorded a win Monday against a formidable Calais squad, and the Tigers earned shutouts against Deer Isle-Stonington and Narraguagus last week to reach the halfway mark on a three-game winning streak.On Monday, Bucksport hosted No. 4 Calais (7-2) and earned a 3-1 win to improve to 5-4 and move into fifth place. The Golden Bucks got two goals from Ella Hosford and one from Johanna Stiles.Sumner hosted Deer Isle-Stonington on Wednesday and completed a season sweep of the Mariners with a 2-0 win. Amanda Brooks scored the first goal for the Tigers with an assist from Scarlet Capitano, and Skylar Soule scored the second unassisted.This is placeholder textThis is placeholder textThe Tigers then took on rival Narraguagus on Saturday and came away with a 6-0 win in Harrington. Soule led the way with two goals and three assists for the Tigers, who also got goals from Brooks, Brianna Flaherty and Sage Soule to improve to the 5-2 and move into eighth place in Class C North.Teams seeded 1-6 in the region this year will earn byes to the quarterfinals. Teams seeded 7-10 will qualify for the preliminary round with No. 7 hosting No. 10 and No. 8 hosting No. 9.Bucksport and Sumner will face off Thursday, Oct. 3, when the Golden Bucks host the Tigers at 4 p.m. Bucksport will then play a road games against Washington Academy (3-3-1; 5 p.m. Friday, Oct. 4), and Sumner will host Calais at noon Saturday, Oct. 5.last_img read more