EU Panel Backs Nasal Glucagon for Hypoglycemia; Romosozumab for Osteoporosis

Megan Brooks

October 18, 2019

The European Medicines Agency (EMA) Committee for Medicinal Products (CHMP) has recommended approval of the first nasal glucagon product (Baqsimi, Eli Lilly Nederland BV) for treatment of severe hypoglycemia in patients with diabetes aged 4 years and older, according to an agency news release.    

The committee also gave a thumbs up to romosozumab (Evenity, UCB Pharma SA) for treatment of postmenopausal women with severe osteoporosis at high risk of fracture.

The FDA approved Baqsimi in July. 

Baqsimi is a novel formulation of glucagon that comes in a single-use dispenser and can be administered through the nose by caregivers. Patients do not need to inhale or breathe deeply after dosing, enabling drug delivery even in unconscious patients.

The efficacy and safety of Baqsimi was demonstrated in two studies of 83 and 70 adults with diabetes and insulin-induced hypoglycemia.

"Baqsimi adequately increased blood sugar levels within 30 minutes of administration and demonstrated to be as efficient and safe as injected glucagon," the EMA said in the statement. Similar results were observed in a pediatric study of 48 patients over the age of 4 years with type 1 diabetes.

The most commonly reported adverse events were headache, nausea, vomiting, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness. Side effects of Baqsimi are similar to injectable glucagon, with the addition of nasal and eye-related symptoms because of the way the medicine is administered.

To ensure proper use of Baqsimi, the CHMP recommended a demonstration kit with a training device, an administration leaflet, and an instructional video.

Romosozumab for Osteoporosis

The CHMP also backed romosozumab for treatment of postmenopausal women with severe osteoporosis at high risk of fracture.

The committee initially rejected romosozumab back in June, as reported by Medscape Medical News, due to safety concerns. It reversed its decision after taking a second look at the data, granting a positive opinion for the restricted indication of severe osteoporosis with high fracture risk, according to an agency news release

Evenity for osteoporosis

The most common side effects with romosozumab are nasopharyngitis and arthralgia. However, "serious cardiovascular events are an important identified risk," the EMA said.

The US Food and Drug Administration (FDA) approved romosozumab earlier this year after first rejecting it. It has a black box warning for cardiovascular events.

Romosozumab, a bone-forming monoclonal antibody, can decrease the number of osteoporotic fractures, including vertebral and nonvertebral fractures, in postmenopausal women with severe osteoporosis and at high risk of fractures, the EMA said.

Romosozumab was evaluated in an extensive phase 3 program that included two large fracture trials comparing it to either placebo or an active comparator in nearly 11,000 postmenopausal women with osteoporosis.

A final decision by the European Commission (EC) on romosozumab is expected by the end of this year.

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