Bristol-Myers Squibb, AstraZeneca present analysis of dapagliflozin studies
PRINCETON, N.J. — Bristol-Myers Squibb and AstraZeneca presented an analysis Wednesday of 14 clinical trials at the American Heart Association’s Scientific Sessions in Orlando, Fla., the companies said.
The phase-2b and phase-3 trials all involved the investigational Type 2 diabetes drug dapagliflozin and, the companies said, showed that use of the drug did not lead to an unacceptable risk to adult patients’ cardiovascular health compared with other treatments.
The analysis included 6,228 patients, with 4,287 taking dapagliflozin and 1,941 taking other drugs.
"This comprehensive analysis provides valuable information that can be used to better understand cardiovascular safety profile of dapagliflozin as a monotherapy or as an add-on therapy to common antidiabetic treatments," Bristol-Myers Squibb SVP global development and medical affairs Brian Daniels said.
GSK announces results of late-stage clinical trial for albiglutide
LONDON — GlaxoSmithKline announced the results from the first of eight phase-3 clinical trials that examined the efficacy of albiglutide in the treatment of Type 2 diabetes.
The Harmony 7 trial was a 32-week, head-to-head, open-label, noninferiority study that compared albiglutide, an investigational once weekly glucagon-like peptide-1 agonist, with once-daily liraglutide. According to the results, patients administered GSK’s drug saw a 0.78% reduction in HbA1C, while patients administered liraglutide saw a 0.99% reduction in HbA1C.
“While the prespecified margin of noninferiority was not met, these topline data support continued progression towards registration of albiglutide as a possible future once weekly treatment for Type 2 diabetes,” GSK chairman of research and development Moncef Slaoui said. “This is the first of eight phase-3 studies to conclude and we continue to look forward to receiving the results of the remaining studies which will provide a more complete assessment of the profile of albiglutide in Type 2 diabetes,” he added.
GSK said that initial results from the remaining seven phase-3 studies will become available over the course of the next several months.
Need for more convenient therapies, competition from generics, biosimilars spurs RA drug development
MOUNTAIN VIEW, Calif. — The increase in the number of people with rheumatoid arthritis, and the challenges posed to drug makers by generics, is encouraging the development of new drugs for the disease, according to a new report by Frost & Sullivan.
The report, released Thursday, found that the incidence of the disease was set to go from 2010’s 2.4 million to 2.6 million in 2017. But the lack of a convenient and safe treatment option without adverse side effects has set the stage for a wave of drug launches in the near future, and many of those drugs could become blockbusters. Many of the injectable biotech drugs currently available for RA come with serious side effects, particularly tumor necrosis factor blockers, which work by blocking the immune-system protein that cause RA, but also can lead to dangerous and potentially fatal side effects like infections and cancer.
Drugs for RA had sales of $5.78 billion in 2010, expected to increase to $8.34 billion in 2017, the report found.
"With the number of biologics on the market and in development for RA, the RA treatment market is becoming crowded," Frost & Sullivan industry manager Jennifer Brice said. "Biologics entering this market must be able to show efficacy and safety data that is comparable, if not superior, to TNF blockers to gain any market share."
Some drugs for treating RA will soon lose patent protection and face competition from biosimilars, such as Pfizer’s and Amgen’s Enbrel (etanercept), whose patent expires next year. While this could increase treatment access, it also will dampen revenues for the companies that developed the treatments, meaning newer drugs are needed. Drugs under development include Pfizer’s CP-690550 (tasocitinib) and Rigel Pharmaceuticals’ R788 (fostamatinib), both oral medications.