Guest guest Posted December 8, 2004 Report Share Posted December 8, 2004 Title Serono knocks Antegren (natalizumab) data Date Published 10/11/2004 Author initials Hina Author surname Radia Author affiliation Hospital Pharmacist Source PharmaTimes Resource Links Link – registration required Abstract Serono, has hit back at the release of one-year data from a late-stage trial of Antegren (natalizumab), calling it “disappointingly incomplete.” The study which concluded that natalizumab significantly reduced the rate of relapses in MS patients was reported on DrugInfoZone on 8th Nov 2004.However, Serono has pointed out that there were no specific relapse data, no disability data, no information on the placebo-treated patients and no combination data from Elan/Biogen Idec’s second Phase III study versus Biogen’s Avonex (interferon beta-1a). Furthermore, it noted that serious infections amongst natalizumab receivers were double that of the placebo group, and said it was “shocked” that serious hypersensitivity reactions had already been observed at one year. “It is far from side effect free,” Serono noted, adding: “It is difficult to understand how this product could be positioned” as it believes Antegren will fail to see a rapid US uptake without long term or head to head data. The report notes that Rebif had four years of data and had already demonstrated superiority against Avonex, allowing it to quickly stamp its mark on the crucial US market. Categories BNF Category > 8: Malignant disease and immunosuppression > 8.2 Drugs affecting the immune response > 8.2.3 Rituximab and alemtuzumab Medical Specialty > Neurology > Multiple sclerosis Medicines Information > Pharmaceutical Industry Printer Friendly Version Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 8, 2004 Report Share Posted December 8, 2004 Thanks Tom. It is scary what they are trying to push on us for the almighty dollar. On 8-Dec-04, at 7:01 AM, tom bayuk wrote: > Title > Serono knocks Antegren (natalizumab) data > > Medicines Information > Pharmaceutical Industry > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 27, 2004 Report Share Posted December 27, 2004 It's new name is Tysabri, it has to be administered at an infusion center because it is given intravenously. Most neuro docs do not have contacts with infusion centers but they will have to get them set up for this drug. My doc told me everything should be in place in about a month. Hope this answers your question, it sounds like a blockbuster drug. - Ben >From: " CK Connie King (1452) " <connie.king@...> >Reply-low dose naltrexone ><low dose naltrexone > >Subject: [low dose naltrexone] Antegren >Date: Mon, 27 Dec 2004 14:23:11 -0500 > >I understand that Antegren has been approved. Does anyone know about >how long it takes to get an approved medication to the pharmacies? Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.