Orphan drug designation for Tolera’s diabetes drug
KALAMAZOO, Mich. The Food and Drug Administration has granted orphan drug designation to an investigational treatment for diabetes.
Tolera Therapeutics said Tuesday that the FDA had given the designation to TOL101, a monoclonal antibody for treating recent onset immune-mediated Type 1 diabetes. The drug is designed for patients aged 16 years and younger.
The FDA gives orphan drug designation to treatments for diseases and conditions that affect fewer than 200,000 people annually in the United States; though an orphan drug still is subject to the same regulatory scrutiny as any drug, the designation waives government filing fees and provides tax credits related to development costs and other support.
“We are pleased with this designation,” Tolera CEO John Puisis said. “Clinicians and patients need an effective and safe means to modulate the immune system, particularly for juvenile diabetes patients.”
Pfizer voluntarily withdraws Mylotarg
SILVER SPRING, Md. Pfizer has withdrawn one of its cancer drugs from the market at the request of the Food and Drug Administration amid concerns about its safety and efficacy, the FDA said Monday.
The drug maker started the voluntary withdrawal of the drug Mylotarg (gemtuzumab ozogamicin), used to treat acute myeloid leukemia, following the abrupt halting of a post-marketing trial in which patients taking Mylotarg with chemotherapy showed no clinical benefit and also died at a higher rate than those taking chemotherapy alone. Wyeth, now part of Pfizer and the original developer of the drug, started the trial in 2004. The drug was approved under the FDA’s accelerated approval program in 2000 for patients aged 60 and older with AML.
“Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer,” FDA Center for Drug Evaluation and Research Office of Oncology Drug Products director Richard Pazdur said in a statement. “However, a confirmatory clinical trial and years of post-marketing experience with the product have not shown evidence of clinical benefit in patients with AML.”
Walmart inks deal with Lilly to offer pharmacy patients Humulin
INDIANAPOLIS The nation’s largest retailer has teamed up with a drug company to provide an affordable insulin option for people with diabetes.
Lilly’s Humulin will be offered by mid-September to Walmart pharmacy patients under the dual-branded name Humulin ReliOn, including 10 mL vials of Humulin R U-100, Humulin N and Humulin 70/30 formulations.
"With diabetes reaching epidemic proportions in America, it’s more important than ever for participants in the healthcare system to work together to provide solutions to help people successfully manage this condition," said Keith Johns, Lilly’s senior director for insulins in the United States. "At Lilly, we strive to provide innovative, cost-effective therapies that help patients manage their diabetes. And as the nation’s largest retailer, Walmart touches more consumers than any other retail organization in the country. This collaboration offers a unique opportunity to provide a low-cost therapy to large numbers of people affected by diabetes."
Along with Humulin ReliOn insulin, Walmart also offers $9 diabetes management products, including the ReliOn Ultima blood glucose meter, the ReliOn Ultima blood glucose test strips (20 ct) and the ReliOn A1c test (glycated hemoglobin).
"Our ReliOn diabetes management products offer customers access to quality, affordable products that allow our customers to save money and live better, healthier lives," said Sandy Kinsey, Walmart’s VP pharmacy merchandising, health and wellness. "With this new offering of Humulin ReliOn insulin, Walmart underscores our commitment to helping people affected by diabetes manage their healthcare needs."