Mylan generic drug for HIV/AIDS receives tentative FDA approval through PEPFAR
PITTSBURGH — Under the President’s Emergency Plan for AIDS Relief, the Food and Drug Administration has given tentative approval to a generic HIV and AIDS drug made by Mylan, the company said.
The drug maker’s Mylan Labs subsidiary received tentative approval for atazanavir sulfate and ritonavir tablets in the 300-mg/100-mg strength. The FDA’s tentative approval of the drug under PEPFAR means it will be eligible for purchase in certain developing countries.
Mylan said the drug was the first heat-stable, fixed-dose combination of the two drugs. The World Health Organization also "pre-qualified" the drug as a second-line treatment option for HIV and AIDS, the company said.
Atazanavir sulfate is a generic version of Bristol-Myers Squibb’s Reyataz, while ritonavir is a generic version of Abbott Labs’ Norvir.
Lilly study to determine why many diabetes patients don’t reach blood-glucose goals
INDIANAPOLIS — Many people with Type 2 diabetes have managed to integrate the treatments they must take into their daily lives, but many do not reach their blood-glucose goals after they start insulin therapy.
Drug maker Eli Lilly is partnering with Brigham and Women’s Hospital in Boston in a study that started in July and has enrolled 4,500 people in 17 countries to find out why many people with the disease resist a progression of insulin therapy.
Dubbed "MOSA1c," the study will gather data on insulin use, interactions between people who have and are treating diabetes and other factors involved in the progression of treatments.
"Fewer than half of people with diabetes reach their target goals for glycemic control, putting them at risk for complications like blindness, amputation, heart disease and kidney failure," Brigham and Women’s Hospital physician, Harvard Medical School professor and study investigator William Shrank said. "The goal of this study is to determine the barriers that prevent patients from optimizing their insulin treatment, whether that is a lack of communication, health system hurdles or emotional responses."
FDA issues draft guidance to investigators, manufacturers of artificial pancreas systems
SILVER SPRING, Md. — In an effort to help advance the development of devices that automatically monitor blood glucose and provide proper insulin doses in people with Type 1 diabetes, the Food and Drug Administration has issued draft guidance to help investigators and manufacturers as they develop and seek approval for these products.
The FDA said the development for artificial pancreas device systems potentially could reduce the risk of dangerous complications caused by Type 1 diabetes, such as extreme blood-glucose levels, among others. The agency’s draft guidance includes such recommendations as a three-phase clinical study progression in order for studies to move to an outpatient setting as quickly as possible, the FDA said.
“The FDA is focused on improving the process for the study and approval of artificial pancreas systems, and developed this guidance to provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works.”
Type 1 diabetes is a condition that occurs when the immune system attacks insulin-producing pancreatic beta cells, thus forcing patients to rely on injections, pumps or other devices to maintain their blood-glucose levels.
For the full draft guidance, click here.