Rhythm Pharmaceuticals, Inc. (NASDAQ: RYTM) shares fade Wednesday, as the company, aa commercial-stage biopharmaceutical company 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 six years old and older.
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.
“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.”
RYTM shares forfeited seven cents, or 1.7%, to $4.13.
