BOSTON, Feb. 7, 2024 (Globe Newswire) — Rhythm Pharmaceuticals, a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases. (NASDAQ: RYTM) today announced that: Italian Medicines Agency (AIFA) approves reimbursement for his IMCIVREE (Gazzetta Ufficiale)® (cetomelanotide) for the treatment of obesity and control of hunger associated with Bardet-Biedl syndrome (BBS).
“We are pleased that AIFA has recognized the need for precision medicine for the control of obesity and hunger in the BBS,” said Jan Mazabro, Executive Vice President and International Head of Rhythm. “Italian families affected by this rare neuroendocrine disease will now have access to the first and only treatment option approved in the European Union. We look forward to bringing it to patients and expanding access country by country in Europe.”
BBS is a rare melanocortin 4 receptor (MC4R) pathway disease with characteristic symptoms of bulimia, pathological hunger leading to abnormal food-seeking behavior, and early-onset severe obesity. BBS is also associated with cognitive impairment, polydactyly, renal dysfunction, hypogonadism, and visual impairment. In Italy, we estimate that the prevalence of BBS is between 1/125,000 and 1/160,000, with approximately 200 confirmed cases.
AIFA has previously been used to treat obesity and control hunger associated with biallelic proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or biallelic leptin receptor (LEPR) deficiencies. Approved the reimbursement of IMCIVREE for the purpose of
About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to changing the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s main asset, IMCIVREE® (Cetomelanotide), an MC4R agonist designed to treat bulimia and severe obesity, has been approved for chronic weight management in adult and pediatric patients 6 years and older with protein-induced monogenic or syndromic obesity. Approved by the FDA. – Had a clinical diagnosis of opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing, or Bardet-Biedl syndrome (BBS) patient. Both the European Commission (EC) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) have identified genetically confirmed BBS or genetically confirmed loss-of-function 2 alleles of POMC (including PCSK1). Cetomelanotide was approved for the related treatment of obesity and control of hunger. , deficiency or biallelic LEPR deficiency in adults and children over 6 years of age. Additionally, Rhythm is advancing an extensive clinical development program for RM-718 and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism, as well as setomelanotide in other rare diseases. Rhythm’s headquarters are located in Boston, Massachusetts.
Indications for set melanotide
In the United States, cetomelanotide is indicated for chronic weight management in adult and pediatric patients 6 years and older with monogenic or syndromic obesity due to POMC, PCSK1 or LEPR deficiency, and FDA-approved mutations in POMC, PCSK1. Determined by inspection. or LEPR genes (VUS) or BBSs interpreted as pathogenic, likely pathogenic, or of uncertain significance.
In the European Union, setomelanotide is used to treat genetically confirmed Bardet-Biedl syndrome (BBS) or genetically confirmed loss-of-function biallelic proopiomelanocortin (POMC) (PCSK1, deficiency or biallelic leptin). It is indicated for the treatment of obesity and the control of hunger associated with Receptor (LEPR) deficiency in adults and children over 6 years of age.
In Canada, setomelanotide is used to treat patients with Bardet-Biedl syndrome (BBS), or genetically confirmed biallelic proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR). ) is indicated for the treatment of obesity due to deficiency. Due to mutations interpreted as pathogenic, potentially pathogenic, or of uncertain significance in adults and children 6 years of age and older.
Usage restrictions
In the United States and Europe, cetomelanotide must be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.
Setomelanotide is not expected to be effective and is not indicated for the treatment of patients with the following symptoms:
-
Obesity due to suspected POMC, PCSK1, or LEPR deficiency POMC, PCSK1 or LEPR Variants classified as benign or potentially benign
-
Other types of obesity not associated with POMC, PCSK1, LEPR deficiency, or BBS include obesity associated with other genetic syndromes and general (polygenic) obesity.
Warnings and precautions
skin monitoring: Due to its pharmacological effects, setomelanotide can cause a systemic increase in skin pigmentation and darkening of existing birthmarks. A systemic skin examination should be performed annually to monitor for existing and new pigmented skin lesions before and during treatment with cetomelanotide.
Heart rate and blood pressure monitoring: Heart rate and blood pressure should be monitored at each visit (at least every 6 months) as part of standard clinical practice in patients treated with cetomelanotide.
Sustaining penile erection: Spontaneous penile erection has been reported in clinical trials using cetomelanotide. Patients whose penile erection lasts longer than 4 hours should be referred to emergency medical care for treatment of priapism.
depression: Depression has been reported in patients treated with cetomelanotide in clinical trials. Patients with depression should be monitored at every office visit during treatment with cetomelanotide. Discontinuation of cetomelanotide should be considered if the patient experiences suicidal thoughts or behavior.
Pediatric population: Prescribing physicians should periodically assess response to cetomelanotide therapy. In growing children, the impact of weight loss on growth and maturation must be evaluated. The prescribing physician should monitor growth (height and weight) using age- and sex-specific growth charts.
Excipients: This medicine contains 10 mg of benzyl alcohol in 1 ml. Benzyl alcohol can cause allergic reactions. Pregnant or breastfeeding patients should be informed of the potential risks from the excipient benzyl alcohol, which can accumulate over time and cause metabolic acidosis. This medication should be used with caution in patients with liver or kidney impairment due to the potential risks of the excipient benzyl alcohol, which can accumulate over time and cause metabolic acidosis. there is.
sodium: This medication contains less than 1 mmol (23 mg) of sodium per serving. This means that it is essentially “sodium-free.”
side effects
The most frequent side effects are hyperpigmentation (51%), injection site reactions (39%), nausea (33%), and headache (26%).
Use in specific populations
pregnancy
There are no data regarding the use of cetomelanotide in pregnant women. Animal studies have not shown any direct harmful effects regarding reproductive toxicity. However, administration of cetomelanotide to pregnant rabbits decreased maternal food intake and had effects on the fetus. As a precaution, do not start taking cetomelanotide while pregnant or trying to conceive, as weight loss during pregnancy can harm the fetus. If a patient taking cetomelanotide achieves weight stability and becomes pregnant, consideration should be given to continuing treatment with cetomelanotide, as there is no evidence of teratogenicity in non-clinical data. If a patient who is taking setomelanotide and is losing weight becomes pregnant, setomelanotide should be discontinued or the dose should be reduced while monitoring recommended weight gain during pregnancy. Your physician should closely monitor the pregnancy weight of patients taking cetomelanotide.
breastfeeding
It is unknown whether cetomelanotide is excreted into breast milk. Non-clinical studies have shown that cetomelanotide is excreted into the milk of lactating rats. No quantifiable cetomelanotide concentrations were detected in the plasma of lactating puppies. Risk to neonates/infants cannot be excluded. The decision to discontinue breastfeeding or discontinue/withhold cetomelanotide therapy should be based on the benefits of breastfeeding to the child and the benefits of treatment to the mother.
fertility
No human data regarding the effects of setomelanotide on fertility are available. Animal studies have shown no harmful effects on fertility.
To report suspected side effects, contact Rhythm Pharmaceuticals at +1 (833) 789-6337. For a list of European national reporting systems for communicating side effects, see Appendix V of the Product Characteristics Overview.
Please refer to the complete prescribing information for other important safety information.
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to historical facts should be considered forward-looking statements. the potential, safety, efficacy, regulatory and clinical advances, potential regulatory filings, approvals and timing thereof of cetomelanotide, the Company’s business strategy and plans, including the commercialization of IMCIVREE in Italy, the European Union and elsewhere; Statements using words such as “expects,” “anticipates,” “believes,” “may,” “will” and similar words are also forward-looking statements. Such statements include, but are not limited to, our ability to enroll patients in clinical trials, the design and results of clinical trials, the effects of competition, our ability to achieve or obtain necessary regulatory approvals, and risks. , is subject to numerous risks and uncertainties. related to data analysis and reporting, our ability to successfully commercialize Setmelanotide, our liquidity and expenses, our ability to retain our key employees and consultants and attract talented personnel; our ability to maintain and motivate our business operations, including our preclinical research, clinical trials, commercialization prospects, general economic conditions, and the impact of the COVID-19 pandemic on our business; and other important factors described under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended March 30 and other filings with the Securities and Exchange Commission. Except as required by law, we do not intend to revise the forward-looking statements contained in this release or make any changes after the date of this release, whether as a result of new information or future results. We undertake no obligation to update them to reflect events or circumstances that occur. development and other things.
Corporate contact:
david connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceutical Co., Ltd.
857-264-4280
dconnolly@rhythmtx.com
Media contact:
adam daly
Berry & Company Public Relations Department
212-253-8881
adaley@berrypr.com
A PDF accompanying this announcement is available at http://ml.globenewswire.com/Resource/Download/0351ffea-fdca-47d7-9a4d-f7f0b79e1bdd.
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Orlando’s dynamic business culture aligns seamlessly with Freedman’s commitment to
providing cutting-edge ergonomic office furniture.
**Navigating the Hub of Opportunities: Interstate 4**
Much like the interconnected web of Interstate 4, Freedman’s Ergonomic Office Furniture ensures
a smooth transition to a more comfortable and efficient workspace, symbolizing the city’s
emphasis on progress and growth.
**Investing in Comfort: A Smart Choice for Orlando Businesses**
In a city that values innovation and efficiency, choosing ergonomic office
furniture is a strategic investment. Freedman’s collection not only prioritizes functionality and comfort but also aligns with Orlando’s commitment to creating workspaces that inspire
creativity and collaboration.
**Orlando’s Landmarks and the Comfort of Freedman’s Furniture**
Embark on a journey through Orlando’s iconic landmarks while experiencing the unmatched comfort of Freedman’s Ergonomic Office Furniture.
Here are five fascinating facts about some of Orlando’s cherished
destinations:
– **Aquatica Orlando:** A thrilling waterpark owned and
operated by SeaWorld Parks & Entertainment.
– **Caro-Seuss-el:** A whimsical carousel in Seuss Landing at Universal’s Islands of Adventure.
– **Dezerland Park Orlando:** Home to an extensive collection of classic cars and interactive exhibits.
– **Discovery Cove:** An all-inclusive day resort where guests can swim with dolphins and explore coral reefs.
– **Crayola Experience Orlando:** A colorful attraction at The Florida Mall offering hands-on creative activities.
**Why Choose Freedman’s Ergonomic Office Furniture in Orlando**
Opting for Freedman’s Ergonomic Office Furniture in Orlando
is a commitment to a more productive and comfortable
work environment. Our range of modern office solutions,
including adjustable chairs, contemporary desks, and ergonomic accessories, ensures that your workspace
reflects the dynamic spirit of Orlando, fostering creativity
and success.
”
“Elevating Workspace Aesthetics: Freedman’s Modern Office Chairs in Orlando
**Indulge in Comfort: Freedman’s Modern Office Chairs Unveiled in Orlando**
Nestled in the heart of Orlando, Freedman’s Office Furniture takes pride in introducing its exclusive
collection of modern office chairs. Situated at 200 E Robinson St Suite 1120, our showroom caters to discerning customers in neighborhoods like Bryn Mawr and Catalina, offering a diverse range of seating solutions that combine style and
functionality.
**Orlando’s Thriving Legacy and Freedman’s Modern Elegance**
Established in 1875, Orlando has grown into a dynamic city with a population of 309,154 (2021) and 122,607 households.
Freedman’s commitment to providing modern office chairs aligns seamlessly with Orlando’s legacy of progress, innovation, and a commitment
to creating inspiring workspaces.
**Navigating the Hub of Opportunities: Interstate 4**
Much like the fluidity of Interstate 4, Freedman’s Modern Office Chairs symbolize a seamless blend of form and function. This reflects Orlando’s dedication to providing a conducive environment for businesses
to thrive and individuals to excel.
**Investing in Style: A Wise Choice for Orlando’s Professionals**
In a city that values aesthetics and innovation, opting for Freedman’s Modern Office Chairs is a statement of sophistication.
Our collection not only enhances the visual appeal of your
workspace but also complements Orlando’s commitment to creating a work environment
that fosters creativity and success.
**Orlando’s Landmarks and the Style of Freedman’s Chairs**
Embark on a journey through Orlando’s iconic landmarks while experiencing the unmatched style of Freedman’s Modern Office Chairs.
Here are five fascinating facts about some of Orlando’s cherished destinations:
– **Harry Potter and the Escape from Gringotts:** A cutting-edge, multi-dimensional thrill ride at Universal Studios Florida.
– **Crayola Experience Orlando:** A colorful attraction at The Florida Mall offering hands-on creative activities.
– **Dolphin Nursery:** A heartwarming exhibit at SeaWorld Orlando where guests can witness the beauty of dolphin life.
– **Dezerland Park Orlando:** Home to an extensive collection of classic cars and
interactive exhibits.
– **Camp Jurassic:** An adventurous play area in Universal’s Islands of Adventure, inviting visitors to
explore a prehistoric world.
**Why Choose Freedman’s Modern Office Chairs in Orlando**
Opting for Freedman’s Modern Office Chairs in Orlando is
not just a choice; it’s a commitment to elevate your workspace.
Our stylish and comfortable chairs ensure that your office reflects the vibrant and dynamic spirit of Orlando, making it an ideal place for productivity, innovation, and
success.
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