Novartis’ Tasigna receives priority review from FDA
EAST HANOVER, N.J. The Food and Drug Administration will shorten its review time of a Novartis drug under investigation as a treatment for leukemia, Novartis said Friday.
The agency plans to give priority review to Tasigna (nilotinib) for the treatment of adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia, also known as Ph+ CML, in the disease’s chronic phase. The FDA grants priority review to drugs that it considers to offer major advances in treatment or to provide treatment where no adequate therapy exists, accelerating the standard review time from 10 months to six.
Novartis said that in clinical trials, Tasigna stopped Ph+ CML from progressing to more advanced stages in “significantly” more patients than did the standard of care, Gleevec (imatinib mesylate), also made by Novartis.
“Recently presented data showed that Tasigna surpassed Gleevec in every measure of treatment efficacy designated in the study, including prevention of disease progression at 12 months,” Novartis Pharmaceuticals Division CEO David Epstein said. “Now, this priority review designation brings us one step closer to offering patients who are newly diagnosed with Ph+ CML in the chronic phase a promising new treatment option.”
FDA warns patients about asthma drug risks
ROCKVILLE, Md. Drugs belonging to the class called long-acting beta agonists should never be used alone for treating asthma in patients and should be combined with other asthma drugs, according to a new warning by the Food and Drug Administration, which is requiring that pharmaceutical manufacturers add the warning to the drugs’ product labels.
The FDA conducted an analysis of clinical trials showing that use of the drugs can increase risk of severe worsening of asthma symptoms, requiring children and adults to be hospitalized and sometimes resulting in death. Instead, the agency said, the drugs should be used only in combination with asthma controller medications such as inhaled corticosteroids, and should only be used long term in patients whose asthma is not adequately controlled by asthma controller medications, but should otherwise be used for the short term.
The drugs used in the analysis, also known as LABAs, include GlaxoSmithKline’s Serevent (salmeterol xinofoate) and Foradil (formoterol fumarate), made by Novartis and Schering-Plough Corp. –– now part of Merck & Co. –– as well as combination LABA-inhaled corticosteroid drugs such as AstraZeneca’s Symbicort (budesonide and formoterol fumarate dihydrate) and GlaxoSmithKline’s Advair (fluticasone propionate and salmeterol).
“Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death,” FDA Center for Drug Evaluation and Research Division of Pulmonary and Allergy Products director Badrul Chowdhury said.
Walgreens named ‘innovative healthcare company’ by magazine
DEERFIELD, Ill. “Fast Company” magazine ranked one of the nation’s largest drug store chains among the most innovative companies in the healthcare industry.
Walgreens was recognized for leadership in healthcare services, transforming itself from a pure dispenser of drugs to a community health provider. From its national network of Take Care Clinics, to such health-and-wellness initiatives as chronic disease management program Walgreens Optimal Wellness, the company was highlighted alongside other healthcare innovators like Kaiser Permanente and Cisco. To create this year’s “Most Innovative Companies” issue, the magazine’s editorial team analyzed information on thousands of businesses across the globe and selected which companies defined the many forms of innovation that exist across the business landscape.
“We are thrilled to be named in the pages of ‘Fast Company’ among the world’s most innovative organizations,” said Colin Watts, Walgreen chief innovation officer. “To be recognized for our innovation in health care is especially gratifying as it validates the significant investment and progress we are making toward our goal of truly becoming a trusted community health provider and in making a measurable and important difference in our customers’ and patients’ lives.”
Added Walgreens EVP pharmacy Kermit Crawford, “We are creating an environment in which our nearly 70,000-strong healthcare providers can deliver the full extent of care their training and capabilities allow. In doing so, we are truly transforming Walgreens into a trusted healthcare provider to our customers and patients. Within pharmacy, this includes pharmacists interacting and counseling patients in new ways. Whether taking an active role in diabetes care or other chronic conditions, Walgreens will continue to lead the way in introducing new programs to care for customers and patients.”