GSK drug gets orphan status from FDA
RALEIGH, N.C. The Food and Drug Administration has approved skin cancer treatment elesclomol, developed by GlaxoSmithKline, for orphan status.
The designation means that the drug will be allowed seven years of exclusivity if it is brought to the market. Orphan status is given to drugs treating diseases that affect fewer than 200,000 people in the United States.
Elesclomol, indicated for the treatment of metastatic melanoma, is currently in Phase III trials. GSK and its partner in development Synta Pharmaceuticals have indicated that they plan to begin testing to determine other indications for the drug as well.
ACC speaks out in favor of waiting for results of further Vytorin trials
WASHINGTON With all the fallout from the ENHANCE trial regarding Merck and Schering-Plough’s cholesterol drug Vytorin, there is one positive show of support for the drug and it comes from the American College of Cardiology, according to published reports.
The ACC issued a statement saying that “major clinical decisions [should] not be made on the basis of the ENHANCE study alone [as it deserves] serious thought and follow-up.” The overall incidence rates of cardiac events were nearly identical between both treatment groups and both were generally well tolerated, the statement said, so “there should be no reason for patients to panic.” It added that the ENHANCE trial “is an imaging study and not a clinical-outcome study,” and that conclusions should not be made until three large clinical-outcome trials are presented within the next two to three years.
But, there are still many who feel the drug is unsafe and has been since it was put on the market. Sidney Wolfe, director of Health Research Group at Public Citizen, said that “we first warned against using Vytorin in December 2004” and suggested people should wait at least seven years before taking the treatment as it was not a “breakthrough” drug.
GSK, TB Alliance renew partnership for tuberculosis treatment
LONDON and NEW YORK GlaxoSmithKline and the Global Alliance for TB Drug Development have renewed their joint research program that is designed to improve the treatment of tuberculosis. The collaboration began in 2004 and currently includes some projects that may produce new medicines to attack Mycobacterium tuberculosis, which causes tuberculosis.
The deal has been extended for an additional three years to research tuberculosis and malaria. So far under the deal, the collaboration has seen two drug discovery projects, out of five, in non-clinical studies to have potential benefits in fighting persistent forms of mycobacterium tuberculosis and thereby offer better chances of shortening treatment duration, which currently takes about six months to complete.
“We are encouraged by the success of our pioneering work with GSK, which has nearly doubled the number of TB drug discovery projects in our pipeline,” said Mel Spigelman, TB Alliance director of research and development. “This collaboration is advancing the TB Alliance’s mission to develop revolutionary, faster and better TB treatment regimens by exploring new ways to attack the disease.”