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The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions that could expand treatment options for obesity, weight management, and diabetes management across the European Union. The decisions include two hybrid liraglutide products and a major label extension for semaglutide introducing an oral formulation for weight management. 

Together, the opinions point to broader use of GLP-1 receptor agonist-based therapies across different indications, age groups, and routes of administration.

Ablymico

The CHMP adopted a positive opinion recommending marketing authorization for Ablymico (liraglutide, STADA Arzneimittel) indicated for weight management as an adjunct to a reduced-calorie diet and increased physical activity. 

The medication addresses diverse patient groups with defined BMI thresholds. 

• Adult candidates include those with a BMI of ≥ 30 (obesity) or a BMI ranging from 27-30 (overweight) with at least one weight-related comorbidity, such as dysglycemia, hypertension, dyslipidemia, or obstructive sleep apnea.
• Adolescents aged ≥ 12 years with obesity equivalent to adult BMI of 30 and weighing more than 60 kg are eligible.
• Children aged 6 to < 12 years with obesity (BMI at 95th percentile or above) and a minimum weight of 45 kg also qualify.

Adults must discontinue therapy after 12 weeks on the 3.0 mg daily dose without achieving 5% initial weight loss, while pediatric patients require 4% BMI or BMI z-score reduction within this timeframe.

Ablymico contains liraglutide, a GLP-1 analogue that binds to and activates GLP-1 receptors. GLP-1 is a physiological regulator of appetite and food intake; liraglutide regulates appetite by increasing feelings of fullness while reducing hunger and cravings, leading to lower energy intake.

Ablymico is a hybrid medicine of Saxenda (Novo Nordisk), which gained European Union authorization in March 2015. Both medications share the same active ingredient, although Ablymico employs chemically synthesized liraglutide vs the biologically sourced compound in the reference treatment. Research confirmed adequate quality standards for Ablymico and established bioequivalence with the reference product Saxenda.

The drug will be supplied as a 6 mg/ml injectable solution in a prefilled pen.

Liraglutide STADA

A second liraglutide hybrid, Liraglutide STADA (STADA Arzneimittel), also received a positive opinion as a hybrid medicinal product of Victoza (Novo Nordisk), which has been authorized in the EU since June 30, 2009. It contains chemically synthesized liraglutide and is intended for the treatment of adults, adolescents, and children aged 10 years or older with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. 

Liraglutide STADA can be used as monotherapy when metformin is considered inappropriate because of intolerance or contraindications, or in addition to other medicinal products for the treatment of diabetes.

It will be available as a 6 mg/ml solution for injection in a prefilled pen. Studies have shown that Liraglutide STADA has acceptable quality and is bioequivalent to the reference medicine Victoza.

Wegovy

The CHMP issued a favorable recommendation supporting approval of Wegovy (semaglutide, Novo Nordisk) to add a once-daily oral tablet formulation for weight management. This decision would make Wegovy tablets the first oral GLP-1 receptor agonist developed for weight management in Europe, offered in four dosage strengths: 1.5 mg, 4 mg, 9 mg, and 25 mg. 

Wegovy tablets are indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ≥ 30) or overweight (BMI ≥ 27 to < 30) with at least one weight-related comorbidity, including prediabetes, type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.

Although Wegovy subcutaneous injections are authorized for patients from the age of 12 years, the oral tablets are intended only for adults. The tablet formulation provides a noninjectable alternative to weekly subcutaneous semaglutide, which may be more convenient for some patients.

The safety and effectiveness of Wegovy tablets were assessed in the OASIS 4 phase 3 trial, involving participants who had obesity or overweight with at least one comorbidity. Participants received either Wegovy or placebo along with a reduced-calorie diet and increased physical activity for 64 weeks. Findings showed that patients taking Wegovy tablets reduced an average of 13.61% of their body weight, compared with 2.18% in the placebo group. Furthermore, 76.3% of participants on Wegovy tablets achieved at least 5% body-weight reduction, vs 30.5% of those receiving placebo. 

The most frequent adverse effects were gastrointestinal disorders, including nausea, diarrhea, constipation, abdominal pain, dyspepsia, and vomiting — mainly occurring at the start of treatment. The safety profile of daily oral tablets was comparable to that of weekly Wegovy injections.

The once-daily oral formulation is prescription-only and should be taken on an empty stomach after at least 8 hours of fasting. Patients should wait 30 minutes before eating, drinking, or taking other medicines. 

Next Steps

The European Commission typically issues a final decision within 67 days after the committee adopts its positive recommendation. Comprehensive recommendations for product use for each will be outlined in the summary of product characteristics, which will be published on the EMA website in all official European Union languages after the European Commission grants marketing authorization.