Read the Official PANTHERx Press Release.
PANTHERx® Rare Pharmacy announced today that it was selected by Rhythm Pharmaceuticals as the exclusive U.S. pharmacy distribution partner for IMCIVREE™ (setmelanotide). The drug was approved by the U.S. Food and Drug Administration (FDA) in November 2020 for chronic weight management in adult 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.
Obesity due to POMC, PCSK1 or LEPR deficiency are ultra-rare diseases caused by variants in POMC, PCSK1 or LEPR genes that impair the melanocortin-4 receptor (MC4R) pathway, which 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 MC4R agonist, IMCIVREE is designed to restore impaired MC4R pathway activity arising due to genetic deficits.
“As the exclusive U.S. distribution partner for IMCIVREE, PANTHERx is pleased to provide innovative, life-changing medicines and award-winning white-glove services to people living with obesity due to POMC, PCSK1 or LEPR deficiency,” said Rob Snyder, President of PANTHERx. “PANTHERx’s partnership with Rhythm advances our mutual dedication to improving the lives of members.”
PANTHERx supports tens of thousands of patients across the country, addressing the unique needs of every patient and assisting with their personal journey. Our proprietary RxARECARE® programs and SWFT® technology systems have allowed PANTHERx to create fully customizable programs for the 25+ rare and orphan medications dispensed. Communications and support services are tailored to the desires of each patient and the requirements of their life-changing medications. PANTHERx, with its evolving suit of personalized services and culture of sincere care, continues to define rare pharmacy.
For more information about the symptoms, diagnosis, and treatment of obesity due to POMC, PCSK1, or LEPR deficiency please click here.
About PANTHERx® Rare Pharmacy
PANTHERx Rare Pharmacy, part of Envolve Pharmacy Solutions, is one of the largest and fastest growing rare pharmacies in the United States. PANTHERx Rare transforms lives by delivering medicine breakthroughs, clinical excellence, and access solutions to patients afflicted with rare and devastating conditions. Although the incidence is as common as diabetes, less than 7% of the 7,000 known rare and devastating disorders have an approved therapy. Changes in federal policy and advances in science have led to a surge in FDA orphan drug approvals, providing tremendous hope to the rare disease community.
PANTHERx was recently awarded Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy (NASP) and earned the inaugural Accredited Distinction in Rare Diseases and Orphan Drugs from the Accreditation Commission for Health Care (ACHC). PANTHERx is a three-time winner of the prestigious MMIT Patient Choice Award, including the 2020 honor. PANTHERx is headquartered in Pittsburgh, Pennsylvania, licensed in all 50 states, and holds accreditations from URAC, NABP, and ACHC.
IMCIVREE Indication and Usage
IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1, or LEPR deficiency confirmed by genetic testing.
IMCIVREE is not indicated for the treatment of patients with obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign, or for other types of obesity associated with other genetic syndromes and general (polygenic) obesity.
Important Safety Information
WARNINGS AND PRECAUTIONS
- Spontaneous penile erections in males, sexual adverse reactions in females, and depression and suicidal ideation have occurred with IMCIVREE.
- IMCIVREE may cause generalized increased skin pigmentation and darkening of
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.
Most common adverse reactions (incidence ≥23%) were injection site reactions, skin hyperpigmentation, nausea, headache, diarrhea, abdominal pain, back pain, fatigue, vomiting, depression, upper respiratory tract infection, and spontaneous penile erection.
Please see full Prescribing Information available at www.IMCIVREE.com/hcp for additional Important Safety Information