The European Commission has expanded the marketing authorization for Rhythm Pharmaceuticals’ (NASDAQ:RYTM) IMCIVREE (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients six years of age and older.
BBS is a rare genetic disease that affects approximately 2,500 people in the European Union and UK. People living with BBS may experience insatiable hunger, also known as hyperphagia, and severe obesity beginning early in life. Approximately 1,500 patients have been diagnosed with BBS and are now being cared for at academic settings in the European Union and UK.
Under the terms of a revenue interest financing agreement with HealthCare Royalty Partners, Rhythm is now eligible to receive an additional investment of $37.5-million following European Commission marketing authorization of setmelanotide for BBS.
Rhythm had received an initial investment of $37.5-million from HealthCare Royalty as a result of setmelanotide’s approval by the FDA. And the company remains eligible for an additional investment of $25-million, which would be payable on achieving certain agreed sales milestones in 2023.
Rhythm also announced that Health Canada has granted priority review for Rhythm’s new drug submission for setmelanotide, indicated in adult and pediatric patients six years of age and older with impairments in the MC4R pathway due to genetic diseases, for the treatment of obesity and control of hunger in BBS, or biallelic pro-opiomelanocortin, proprotein convertase subtilisin/kexin type 1, or leptin receptor deficiency.
“These two important regulatory milestones underscore the global unmet need to treat the hyperphagia and severe obesity associated with these rare MC4R pathway diseases,” David Meeker, M.D., chairman, president and CEO of Rhythm, said in a statement.
“We are working closely with health technology assessment bodies and payers throughout the EU on a country-by-country basis to achieve market access and reimbursement in order to make IMCIVREE available to eligible patients as rapidly as possible,” he added.
