FDA Approvals Roundup: Orladeyo, Saxenda

RoundupsRoundupsRegulatory NewsRegulatory News | 09 December 2020 |  By 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approval
Orladeyo approved as prophylactic for hereditary angioedema
BioCryst’s Orladeyo (berotralstat) has been approved for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and children aged 12 years or older, making it the first orally administered, nonsteroidal option for preventing these attacks.
HAE is a rare genetic condition characterized by recurring episodes of swelling in the face, hands, feet, or genitals, as well as lung airways and abdominal walls.
The approval of Orladeyo was supported by findings from APeX-2, a phase 3, randomized, double-blind, placebo-controlled, parallel-group study with 96 patients. Investigators reported a significant reduction in the number of HAE attacks among treated patients at 24 weeks compared with baseline. That trend continued through 48 weeks, when treated patients showed a reduction in monthly attack rates, from a mean of 2.9 attacks at baseline to 1.0 attacks. In the long-term, open-label APeX-S safety trial of 475 patients, those completing 48 weeks of therapy had a mean monthly attack rate of 0.8 attacks.
New indication
Saxenda handed new indication for treating obesity in adolescents
Novo Nordisk’s Saxenda (liraglutide injection) has received an expanded indication for treating obesity in adults and adolescents aged 12-17 years combined with a reduced-calorie diet and increased physical activity.
This is the first approval in more than a decade for a treatment for obesity in adolescents. The glucagon-like peptide-1 (GLP-1) receptor agonist was approved in 2014 for chronic weight management in adults with at least one weight-related comorbidity, also combined with diet and physical activity.
Saxenda’s safety and efficacy in adolescents with obesity was demonstrated in a phase 3a trial with 251 patients. The 56-week randomized, placebo-controlled, double-blind study investigated the effects of Saxenda compared with placebo for weight management in the indicated population. Results showed significant reductions in treated patients in the body mass index standard-deviation score (BMI-SDS), BMI, mean body weight, and other weight-related endpoints compared with placebo patients. At week 56, the change from baseline BMI favored Saxenda over placebo (BMI-SDS, estimated difference between the two groups: −0.22; P = .002). In all, 43.3% of treated patients and 18.7% of placebo patients had a 5% reduction in BMI, and 26.1% and 8.1%, respectively, a reduction of 10%.
Saxenda is shighly similar to the human GLP-1 hormone that regulates appetite and food intake through its activity in the areas of the brain that regulate appetite.



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Tags: FDA, US

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