Rhythm Pharmaceuticals and Medison Pharma Partner to Commercialize IMCIVREE™ (setmelanotide) in Israel
BOSTON and PETACH TIKVA, Israel, July 22, 2021 (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, and Medison Pharma, a leading commercial partner for highly innovative therapies in international markets, today announced an exclusive distribution agreement for Medison to commercialize Rhythm’s melanocortin-4 (MC4) receptor agonist IMCIVREE™ (setmelanotide) in Israel.
IMCIVREE was approved on November 2020 by the U.S. Food and Drug Administration (FDA) for chronic weight management in adults and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing.
“We are committed to delivering IMCIVREE to people living with rare genetic diseases of obesity around the world, and we believe Medison will be a strong partner as we extend our commercial footprint into Israel,” said Yann Mazabraud, Rhythm’s Executive Vice President and Head of International. “Medison has a robust platform and a track record of successfully advancing programs through the registration and reimbursement processes, and we look forward to working together to bring IMCIVREE to patients with POMC, PCSK1 and LEPR deficiency obesity.”
Obesity due to POMC, PCSK1 or LEPR deficiency are ultra-rare diseases caused by variants in POMC, PCSK1 or LEPR genes that impair the MC4 receptor pathway, which is a pathway in the hypothalamus that is responsible for regulating hunger, energy expenditure and consequently body weight. People living with obesity due to POMC, PCSK1 or LEPR deficiency struggle with extreme, insatiable hunger beginning at a young age, resulting in early-onset, severe obesity. As an MC4 receptor agonist, IMCIVREE is designed to restore impaired MC4 receptor pathway activity arising due to genetic deficits upstream of the MC4 receptor.
About Rhythm Pharmaceuticals
About Medison Pharma
IMCIVREE™ (setmelanotide) Indication
Limitations of Use
Important Safety Information
WARNINGS AND PRECAUTIONS
Disturbance in Sexual Arousal: Sexual adverse reactions may occur in patients treated with IMCIVREE. Spontaneous penile erections in males and sexual adverse reactions in females occurred in clinical studies with IMCIVREE. Instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.
Depression and Suicidal Ideation: Some drugs that target the central nervous system, such as IMCIVREE, may cause depression or suicidal ideation. Monitor patients for new onset or worsening of depression. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors.
Skin Pigmentation and Darkening of Pre-Existing Nevi: IMCIVREE may cause generalized increased skin pigmentation and darkening of pre-existing nevi due to its pharmacologic effect. This effect is reversible upon discontinuation of the drug. Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin 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.
USE IN SPECIFIC POPULATIONS
Treatment with IMCIVREE is not recommended for use while breastfeeding.
See Full Prescribing Information for IMCIVREE.