First treatment approved for chronic rhinosinusitis with nasal polyps
The FDA approved dupilumab (Dupixent) to treat adults with nasal polyps accompanied by chronic rhinosinusitis. It is the first treatment approved for inadequately controlled chronic rhinosinusitis with nasal polyps. It is administered by subcutaneous injection and patients may self-inject the drug after proper instruction.
The efficacy and safety of dupilumab, an interleukin-4 receptor alpha antagonist, were established in two studies of 724 patients 18 years and older with chronic rhinosinusitis with nasal polyps who were symptomatic despite taking intranasal corticosteroids. Patients who received dupilumab had statistically significant reductions in their nasal polyp size and nasal congestion compared with the placebo group. In addition, patients taking dupilumab reported an increased ability to smell and required less nasal polyp surgery and oral corticosteroids.
The most common adverse reactions in patients with chronic rhinosinusitis with nasal polyps are gastritis, arthralgia, conjunctivitis, insomnia, eosinophilia, and injection site reactions. Dupilumab may cause serious eye problems, such as conjunctivitis and keratitis, and patients should be instructed to report new-onset or worsening eye symptoms to their healthcare provider.
Dupilumab was originally approved for patients with eczema not controlled adequately by topical therapies; it is also an add-on maintenance treatment for patients 12 years and older with moderate-to-severe eosinophilic asthma or with oral corticosteroid-dependent asthma.
Emgality approved for cluster headache prevention
The FDA approved Eli Lilly's galcanezumab-gnlm (Emgality) for the treatment of cluster headache in adults. It is the first drug approved to reduce the frequency of episodic cluster headache attacks. Galcanezumab-gnlm, a calcitonin gene-related peptide antagonist, was previously approved to prevent migraine and is administered by patient self-injection. Prior to use, the patients need to receive instruction on proper subcutaneous administration of the drug.
In clinical trials, galcanezumab-gnlm demonstrated effectiveness for the treatment of episodic cluster headache compared with placebo in 106 patients. The trial measured the average number of cluster headaches per week for 3 weeks and compared the average changes from baseline in the galcanezumab-gnlm and placebo groups. During the 3-week period, patients taking galcanezumab-gnlm experienced 8.7 fewer weekly cluster headache attacks than they did at baseline, compared with 5.2 fewer attacks for patients on placebo.
The FDA notes that there is a risk of hypersensitivity reactions with galcanezumab-gnlm use, which can occur days after administration and may be prolonged. The most common adverse reactions reported by participants in the clinical trial were injection site reactions.
Liraglutide approved for pediatric patients with type 2 diabetes
The FDA expanded the indications for liraglutide (Victoza) to include pediatric patients age 10 years or older with type 2 diabetes mellitus (T2DM). Liraglutide is a glucagon-like peptide-1 receptor agonist already approved as an adjunct to diet and exercise for treatment of T2DM in adults.
The approval was based on data from the ELLIPSE trial, which was conducted in 134 children and adolescents age 10 years and older with T2DM. Patients were randomly assigned to receive up to 1.8 mg liraglutide daily or placebo, in addition to metformin (with or without basal insulin). After 26 weeks, patients who received liraglutide experienced a mean hemoglobin A1C level decrease of 0.64%, whereas placebo patients experienced an increase of 0.42%, correlating to a treatment difference of -1.06% (P < .001).
In the trial, the risk of hypoglycemia was found to be higher with liraglutide in pediatric patients regardless of concomitant antidiabetic therapies.