Rhythm Pharmaceuticals Launches IMCIVREE® (setmelanotide) in Germany for the Treatment of Obesity and Control of Hunger Associated with POMC or LEPR Deficiency
BOSTON, June 22, 2022 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity, today announced IMCIVREE® (setmelanotide) is now available to patients in Germany.
IMCIVREE, a melanocortin-4 receptor (MC4R) agonist, last year received marketing authorization from the European Commission for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years old and older.
“We are excited to make IMCIVREE available to treat patients in Germany living with the hyperphagia and severe obesity caused by these rare MC4R pathway diseases,” said Yann Mazabraud, Executive Vice President, Head of International at Rhythm. “We thank the German authorities for their recognition of the need for a therapy to treat obesity and control hunger due to POMC and LEPR deficiencies as we work to transform the lives of patients living with these diseases.”
The German Federal Joint Committee (G-BA) earlier this year voted to exclude IMCIVREE from its lifestyle exemption list for POMC or LEPR deficiency obesity. In Germany, drugs classified as lifestyle drugs, which include those designed to effect weight loss, smoking cessation or hair loss, are not eligible for reimbursement. IMCIVREE, which is the first precision medicine designed to induce weight loss and control of hunger to receive such an exemption, now is eligible for national coverage and reimbursement.
About Rhythm Pharmaceuticals
In the EU and Great Britain, IMCIVREE is indicated for the treatment of obesity an the control of hunger associated with genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. IMCIVREE should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.
Rhythm’s Type II variation application to the European Medicines Agency (EMA) for the treatment of obesity and control of hyperphagia in adult and pediatric patients 6 years of age and older with BBS is under review. The Company is also continuing to advance the most comprehensive clinical research program ever initiated in MC4R pathway diseases, including the pivotal Phase 3 EMANATE clinical trial evaluating setmelanotide in four independent sub-studies in patients with obesity due to POMC insufficiency caused by heterozygous variants in the POMC or PCSK1 genes, LEPR insufficiency caused by heterozygous variants in the LEPR gene, SRC1 deficiency caused by a variant in the NCOA1 gene, and SH2B1 deficiency caused by a variant in the SH2B1 gene or 16p11.2 deletion encompassing the SH2B1 gene. The Phase 2 DAYBREAK trial is evaluating setmelanotide in patients with severe obesity and hyperphagia caused by rare variants associated with 10 prioritized MC4R-relevant genes. Rhythm has also initiated a Phase 3 pediatric trial and a Phase 3 trial evaluating a weekly formulation of setmelanotide.
IMCIVREE® (setmelanotide) Indication
Limitations of Use
WARNINGS AND PRECAUTIONS
Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.
Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.
Skin Pigmentation and Darkening of Pre-existing Nevi: Generalized increased skin pigmentation and darkening of pre-existing nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmentary lesions.
Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved drugs.
USE IN SPECIFIC POPULATIONS
To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at 833-789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the full Prescribing Information for additional Important Safety Information.