Saxenda (Liraglutide) Set to Become First EMA-Approved Therapy for Adolescent Obesity (12–17 Years)

Mar 28, 2021 17:08 CST Updated 17:08

Novo Nordisk

Insulin Developer and Manufacturer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

European Commission

The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.

March 28, 2021/BioonBIOON/-- Novo Nordisk recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval to expand the indicated population for Saxenda (liraglutide) injection to include adolescents aged 12 to 17 years with obesity. The CHMP’s opinion will now be submitted to the European Commission (EC) for review, which typically renders a final decision within two months.

Over the past 20 years, the global prevalence of overweight children and adolescents has doubled, increasing from 1 in 10 to 1 in 5. Currently, more than 124 million children and adolescents worldwide are living with obesity. Adolescents with obesity are more prone to developing weight-related complications at a younger age, such asDiabetesand heart disease. Therefore, it is crucial for adolescents with obesity to receive the necessary support to effectively manage their weight.

If approved, Saxenda will become the first therapy for obesity in adolescents (aged 12–17 years) approved in the European Union. The medication will be indicated for the treatment of obese adolescents (aged 12–17 years) weighing >60 kg and with an initial body mass index (BMI) equivalent to ≥30 kg/m² in adults, in combination with a healthy diet and increased physical activity.

In terms of U.S. regulatory approval, Saxenda was approved in December 2020FDAApproved Label Update: As an adjunct to a reduced-calorie diet and increased physical activity, for the treatment of adolescent patients (12–17 years) with obesity weighing >60 kg and having an initial body mass index (BMI) equivalent to ≥30 kg/m² in adults.

Saxenda (3.0 mg injection) is the first glucagon-like peptide-1 (GLP-1) receptor agonist developed for weight management, approved in the United States in December 2014 and in the European Union in March 2015 as an adjunct to a reduced-calorie diet and increased physical activity for long-term weight management in adult patients with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity.

Saxenda shares 97% similarity with naturally occurring human GLP-1, a hormone involved in the regulation of appetite and food intake. Like human GLP-1, Saxenda is believed to act in brain regions involved in appetite regulation, including the hypothalamus. The use of Saxenda in adults with obesity has been evaluated in the SCALE clinical program. Since its launch in 2015, more than 1.5 million adult patients worldwide have received treatment with Saxenda.

Obesity – Adolescents (Image source: endocrinologyadvisor.com)

The CHMP’s positive opinion on the label expansion of Saxenda for the treatment of adolescent obesity was supported by data from a Phase 3a clinical trial (NCT02918279) published earlier in 2020 in the New England Journal of Medicine (NEJM). This 56-weekClinical TrialsConducted in 251 obese patients aged 12-17 years, the study investigated Saxenda versus placebo as part of lifestyle therapy (defined as: through healthy nutrition and physical activity)Weight Loss) as an adjunctive therapy, on weight management in patients. In this trial, the primary endpoint was the change from baseline in body mass index (BMI) standard deviation score (SDS) at 56 weeks.

Data show that, compared with placebo, the use of Saxenda as an adjunct to lifestyle therapy significantly reduced BMI-SDS, BMI, mean body weight, and other weight-related endpoints in adolescent patients with obesity. The adverse events observed in the adolescent population were similar to those observed in adults. The most commonAdverse ReactionsGastrointestinal events, including nausea, vomiting, and diarrhea.

Martin Holst Lange, Executive Vice President and Head of Development at Novo Nordisk, stated: “The rising rate of obesity among adolescents worldwide is a public health issue that poses significant challenges to the lives of obese teenagers due to the limited treatment options available. The CHMP’s recommendation for approval of Saxenda for adolescent use marks an important step toward providing treatment options for obese adolescents. This medication can effectively help control their weight when healthy diet and physical activity alone are insufficient.”(Bioon.com)

Original source: Saxenda® recommended forapproval by European Medicines Agency committee for the treatment of obesity in adolescents aged 12–17 years