The federal safety watchdog’s approval, of Lilly’s Baqsimi nasal powder and the delivery device developed by Aptar for treating severe hypoglycemia, was based on two studies comparing a single dose of Baqsimi to a single dose of injected glucagon in a total of 153 adult patients. A third pediatric study involving 48 patients also showed that the nasal glucagon “adequately increased blood sugar levels,” according to the FDA. The approval covers patients with diabetes ages four and older.
Aptar’s Unidose device is a single-use dispenser, in this case designed to deliver 3mg of glucagon, packaged using the company’s Activ-Polymer material to extend shelf time, the company said. Lilly, which acquired Baqsimi when it bought Locemia Solutions in 2015, said it expects to have Baqsimi on the market within a month.
“People who are living with diabetes are at risk of their blood sugar levels falling below the normal range. There are many products on the market for those who need insulin, but until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process,” Center for Drug Evaluation & Research director Dr. Janet Woodcock said in prepared remarks. “This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure. In those situations, we want the process to treat the suffering person to be as simple as possible.”
“Severe hypoglycemia is an unpredictable event for people with diabetes that can happen anytime, anywhere. It’s an experience that can be very stressful and difficult for those helping a person in a low blood sugar emergency,” added Lilly medical affairs VP Dr. Sherry Martin. “The FDA’s approval of BAQSIMI may help people prepare for these moments with an innovative product that has the simplicity of nasal administration.”
“We are pleased to announce that Aptar Pharma’s Unidose powder system has been approved by the FDA for the first intranasally-delivered, needle-free rescue treatment for severe hypoglycemia that provides a more patient-friendly delivery approach. Our active packaging container helps to protect the device and better ensure its quality until the moment of use,” Aptar Pharma president Gael Touya said in a press release. “This project marks a nearly 10-year customer collaboration and once again demonstrates Aptar Pharma’s ability to help our customers develop and launch complex treatments with patient-friendly delivery systems worldwide.”