Clinical trial finds Novartis drug reduces progression of MS
BASEL, Switzerland An investigational drug for treating multiple sclerosis reduced progression of disability by more than 30%, according to results of a late-stage clinical trial recently published in The New England Journal of Medicine.
Novartis conducted two phase 3 trials of FTY720 (fingolimod), an oral treatment for MS, administering 0.5-mg and 1.25-mg doses to more than 2,300 patients. The Swiss drug maker applied for approval of the 0.5-mg dose with the Food and Drug Administration in December on account of its posing lower risk to patients.
In one study, which enrolled 1,272 patients and lasted for two years, patients taking the 0.5-mg dose experienced reductions in the risk of three-month and six-month confirmed disability progression by 30% and 37% compared with placebo, respectively, and got similar results from the 1.25-mg dose. In the one-year study, which enrolled 1,292 patients, the 0.5 mg dose reduced relapses by 52% compared with Biogen Idec’s Avonex (interferon beta-1a), while the 1.25-mg dose reduced them by 38%.
“Innovative science leading to new medicines for MS patients is greatly needed,” National Multiple Sclerosis Society EVP research and clinical programs John Richert said in a statement. “The positive results published in The New England Journal of Medicine showing benefit of fingolimod on the clinical and MRI outcomes assessed is very encouraging to MS patients, their families and their physicians.”
Profession is in ‘revolutionary’ times, says NACDS’ top pharmacy official
NEEDHAM, Mass. Pharmacy practitioners need to recognize that the profession is now in the midst of “revolutionary” changes and adapt to a far more proactive role in patient outreach and community care, a top executive with the National Association of Chain Drug Stores told more than 300 leaders in health care, business, government and community activism here Tuesday.
As the health paradigm shifts, pharmacists need to leverage their strengths as “medication experts” who can coordinate healthcare efforts within the community, and put patients at the center of those efforts, said Edith Rosato, SVP pharmacy affairs for NACDS and president of the NACDS Foundation. Rosato was addressing a meeting of the Massachusetts Health Council, the nation’s the largest and oldest council devoted to health issues.
The subject of her talk: “Transforming Pharmacy Practice: Managing a Changing Environment.” In her address, Rosato tracked community pharmacy’s evolving role and its ability, as a profession, to adapt to changes in the U.S. healthcare system.
“Pharmacy is embarking on revolutionary times,” Rosato asserted. ”It is only fitting that in the nation’s birthplace — Massachusetts — I lay out the importance of revolutionary change in our field. Only by recognizing this change can we learn to adapt our protocols and practices to better position pharmacy in medication adherence activities, which [improving] health outcomes for patients while also reducing overall healthcare expenditures.
“As the face of neighborhood health care, it is not only our duty to transform to better serve our patients — it is our responsibility,” she added.
By utilizing the accessibility and credibility of pharmacy with the effective use of health information technology and management efficiencies, Rosato told members of the council, pharmacists could play an even bigger role in proactive and integrated patient-centric health care. Among the tools they already wield, she said, are medication therapy management services, vaccinations, patient counseling, and prevention-and-wellness programs.
In a bit of irony, Rosato’s appearance in Massachusetts came as voters in this state were dealing the Obama administration a serious setback in its health-reform efforts by electing Republican Scott Brown to succeed Edward Kennedy, one of the Senate’s most vocal champions of health reform before his death last year.
Brown has vowed to fight reform legislation as the 41st Republican senator, and his election breaks the filibuster-proof, 60-vote majority Democrats have held in the Senate.
JDRF, Axxam, Fast Forward to develop diabetes, MS treatments
NEW YORK A group of companies and organizations plan to collaborate to develop new treatments for multiple sclerosis and Type 1 diabetes.
Italian life sciences company Axxam, the Juvenile Diabetes Research Foundation and Fast Forward, the commercial drug development arm of the National Multiple Sclerosis Society, will fund the discovery of new drugs for the two autoimmune diseases.
Axxam will screen its chemical library to identify compounds that can target immune system ion channels, pores in the surface of immune cells that allow the cells to activate. Recent research has shown that the immune cells of patients with MS and Type 1 diabetes have high levels of the Kv1.3 ion channel, and the resulting hyperactivity contributes to dysfunction of the immune system. Meanwhile, the JDRF and Fast Forward will seek to lessen the risk of drug discovery and accelerate the development of new therapies.
“We are pleased to partner with Axxam and JDRF to advance the development of new treatments for [Type 1 diabetes] and MS,” Fast Forward president Timothy Coetzee said.