Xolair approved for adults with nasal polyps
The FDA approved Xolair (omalizumab), an immunoglobulin E (IgE) blocker, for add-on maintenance treatment of nasal polyps in adults ages 18 years or older with inadequate response to nasal corticosteroids.
The approval was based on data from two phase 3 clinical trials evaluating the efficacy and safety of Xolair in adults with inadequate response to nasal corticosteroids. Data showed that patients treated with Xolair had a statistically significant greater improvement from baseline at week 24 on nasal polyp score and nasal congestion score compared with placebo, with improvements observed as early as week 4. Xolair also showed statistically significant improvements on sense of smell score, postnasal drip, and runny nose in both trials. The most common adverse reactions reported included headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness.
Xolair is a product of Genentech and Novartis.
Orladeyo approved to prevent hereditary angioedema attacks
The FDA approved Orladeyo (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older. The drug works by binding to plasma kallikrein and inhibiting its proteolytic activity.
Approval was based on data from phase 3 clinical trials, which showed that Orladeyo 110 mg and 150 mg were associated with 30% and 44.2% reductions, respectively, in the rate of HAE attacks at week 24 compared with placebo. Reductions in HAE attack rates were also sustained through 48 weeks. Patients also reported meaningful improvements in both quality of life and significant reductions in their monthly use of standard of care on-demand medications.
Orladeyo is a product of BioCryst Pharmaceuticals.
Saxenda approved for obesity in adolescents
Saxenda (liraglutide) was approved by the FDA as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in pediatric patients ages 12 years and older with body weight greater than 60 kg (132.3 lb) and an initial body mass index (BMI) corresponding to 30 kg/m2 or greater for adults (obese). The drug was previously approved only for chronic weight management in adults. Saxenda is a product of Novo Nordisk.
Approval was based on data from a phase 3 study in 251 pubertal patients 12 to 17 years of age with BMI corresponding to 30 kg/m2 or greater for adults and at the 95th percentile or greater for their age and sex. In that study, Saxenda achieved a significantly greater reduction in BMI standard deviation score after 56 weeks compared with placebo.
The safety profile of Saxenda in pediatric patients was similar to that seen in adults, with the most common adverse reactions including nausea, vomiting, diarrhea, dizziness, and fever. The use of Saxenda in pediatric patients with type 2 diabetes mellitus has not been established.
Weekly Twirla contraceptive patch now available
Twirla (levonorgestrel and ethinyl estradiol) transdermal contraceptive system is now available for use in women of reproductive potential with a BMI less than 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. The transdermal system delivers 120 mcg of levonorgestrel and 30 mcg of ethinyl estradiol per day with weekly patches for 3 consecutive weeks followed by 1 week without a patch, when withdrawal bleeding is expected.
The patch (less than 1 mm thickness) can be applied to the abdomen, buttocks, or upper torso (excluding breasts).
Twirla is contraindicated in women with a BMI 30 kg/m2 or greater; effectiveness may be reduced in women with a BMI >=25 to <30 kg/m2. The most common adverse reactions reported with Twirla use were application site disorders, nausea, headache, dysmenorrhea, and increased weight. Like other combined hormonal contraceptives, the use of Twirla may increase the risk for a venous thromboembolic event.
Twirla is a product of Agile Therapeutics.