The FDA has announced that it approved Eli Lilly and Company’s Baqsimi single-use intranasal dry powder glucagon for the emergency treatment of severe hypoglycemia. Lilly announced that it had submitted the NDA for Baqsimi in July 2018. The company, which acquired worldwide rights to the nasal glucagon powder from Locemia in 2015, said at the time that it had also filed an MAA with the EMA.
FDA Center for Drug Evaluation and Research Director Janet Woodcock said, “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. 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.”
Lilly Medical Affairs VP Sherry Martin commented, “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. The FDA’s approval of Baqsimi may help people prepare for these moments with an innovative product that has the simplicity of nasal administration.”
According to the agency, the application was supported by data from two efficacy and safety studies in adults with diabetes and a pediatric study of Type 1 diabetes patients over age 4, all of which demonstrated an adequate increase in blood sugar levels for Baqsimi compared to an injection of glucagon.
Baqsimi is delivered via Aptar Pharma’s Unidose Powder System, and according to Aptar, this is the first FDA approval for a product using that system. The company said that this is also the first use of an active packaging system using Activ-Polymer technology developed by Aptar CSP Technologies with one of Aptar Pharma’s drug delivery devices.
Aptar Pharma President Gael Touya said, “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. 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.”
Read the FDA press release.
Read the Eli Lilly and Company press release.
Read the AptarGroup press release.
