IMCIVREE delivered early, significant, and sustained weight reduction1-3
← Swipe left or right to see all tabs →
Weight reduction in patients ≥18 years of age1-4
← Swipe left or right to view →
14-week weight reduction results vs placebo
In patients ≥18 years of age with BBS during the 14-week placebo-controlled period
13x greater weight reduction with IMCIVREE vs placebo1
Weight changes in pivotal and supplemental patients ≥18 years of age with BBS during the 14-week double‑blind, placebo-controlled period*
← Swipe left or right to view →
*Supplemental patients were enrolled after the pivotal cohort had begun treatment. None of the supplemental patients had completed 52 weeks of IMCIVREE treatment at the time of data analysis.
PCPB=placebo-controlled period baseline.
Reference: 1. Haqq AM et al. Lancet Diabetes Endocrinol. 2022;10(12):859-868. doi:10.1016/S2213-8587(22)00277-7. Supplemental appendix available at: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00277-7/fulltext.
24-month long-term extension trial
Results from a long-term extension study in patients with BBS ≥18 years of age (n=6):
IMCIVREE delivered sustained and improved weight reduction at 24 months1*
~15%
reduction in body weight
No new safety signals were observed during long-term administration of IMCIVREE in patients with BBS at 24 months1
One patient discontinued due to an AE unrelated to IMCIVREE1
Long-term extension study design1,2
At completion of an index trial, 19 patients who enrolled in a separate open-label, long-term extension study had received at least 24 months of IMCIVREE2
Patients to be assessed every 3 months until the end of the study (up to 5 years or patient withdrawal)1,2
*Compared with measures at index trial baseline.2
AE=adverse event.
References: 1. Argente J et al. Endocrine Society Annual Meeting. Poster ODP606. June 11-14, 2022. 2. Data on file. Rhythm Pharmaceuticals, Inc. Boston, MA.
Clinically significant ~10% mean weight reduction in patients ≥18 years of age at week 522,3
At 24 months, patients in a long-term extension trial experienced a mean ~15% reduction in body weight4
*ATB=active treatment baseline, defined as the last measurement before the first dose of IMCIVREE, ie, week 0 for IMCIVREE group and week 14 for placebo group.2
†Data shown only include patients who received 52 weeks of IMCIVREE at the time of the analysis.2
‡For patients aged 18 years or older, population sizes ranged from 7 to 15, with n=12 at 52 weeks on active treatment. Error bars are the standard deviation.2
Percentage change in weight in patients ≥18 years of age after 52 weeks (n=12)1
← Swipe left or right to view →
14-week weight reduction results vs placebo
In patients ≥18 years of age with BBS during the 14-week placebo-controlled period
13x greater weight reduction with IMCIVREE vs placebo1
Weight changes in pivotal and supplemental patients ≥18 years of age with BBS during the 14-week double‑blind, placebo-controlled period*
← Swipe left or right to view →
*Supplemental patients were enrolled after the pivotal cohort had begun treatment. None of the supplemental patients had completed 52 weeks of IMCIVREE treatment at the time of data analysis.
PCPB=placebo-controlled period baseline.
Reference: 1. Haqq AM et al. Lancet Diabetes Endocrinol. 2022;10(12):859-868. doi:10.1016/S2213-8587(22)00277-7. Supplemental appendix available at: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00277-7/fulltext.
24-month long-term extension trial
IMCIVREE delivered sustained and improved weight reduction at 24 months1*
~15%
reduction in body weight
No new safety signals were observed during long-term administration of IMCIVREE in patients with BBS at 24 months1
One person discontinued due to an AE unrelated to IMCIVREE1
Long-term extension study design1,2
At completion of an index trial, 19 people who enrolled in a separate open-label, long-term extension study had received at least 24 months of IMCIVREE2
People to be assessed every 3 months until the end of the study (up to 5 years or patient withdrawal)1,2
*Compared with measures at index trial baseline.2
AE=Adverse Reactions
References: 1. Argente J et al. Endocrine Society Annual Meeting. Poster ODP606. June 11-14, 2022. 2. Data on file. Rhythm Pharmaceuticals, Inc. Boston, MA.
Patients were not required to change their diet or exercise routine1
*Patients with data after 52 weeks of treatment.1
IMCIVREE significantly reduced the severity of obesity due to BBS1-4
This chart is a visual representation of what a hypothetical adult with BBS* who started IMCIVREE at 20 years of age may experience in BMI reduction after 1 year and 2 years, based on data from the phase 3 trial and a separate long-term extension trial†
24-month long-term extension trial
IMCIVREE delivered sustained and improved weight reduction at 24 months1,2*
~15%
reduction in body weight
No new safety signals were observed during long-term administration of IMCIVREE in patients with BBS at 24 months1
One patient discontinued due to an AE unrelated to IMCIVREE1
Long-term extension study design1,2
At completion of an index trial, 19 patients who enrolled in a separate open-label, long-term extension study had received at least 24 months of IMCIVREE
Patients to be assessed every 3 months until the end of the study (up to 5 years or patient withdrawal)
*Compared with measures at index trial baseline.2
AE=adverse event.
References: 1. Argente J et al. Endocrine Society Annual Meeting. Poster ODP606. June 11-14, 2022. 2. Data on file. Rhythm Pharmaceuticals, Inc. Boston, MA.
References: 1. Data on file. Rhythm Pharmaceuticals, Inc. Boston, MA. 2. Haqq AM et al. Lancet Diabetes Endocrinol. 2022;10(12):859-868. doi:10.1016/S2213-8587(22)00277-7. Supplemental appendix available at: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00277-7/fulltext. 3. Grossman DC et al; US Preventive Services Task Force. JAMA. 2017;317(23):2417-2426. 4. Argente J et al. Endocrine Society Annual Meeting. Poster ODP606. June 11-14, 2022.
Important Safety Information
Indication
IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Bardet-Biedl syndrome (BBS).
Limitations of Use
IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:
Other types of obesity not related to BBS or other FDA-approved indications for IMCIVREE, including obesity associated with other genetic syndromes and general (polygenic) obesity
WARNINGS AND PRECAUTIONS
Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.
Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.
Skin Pigmentation and Darkening of Pre-existing Nevi: Generalized increased skin pigmentation and darkening of pre-existing nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new 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. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved drugs.
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection
USE IN SPECIFIC POPULATIONS
Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at 833-789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Bardet-Biedl syndrome (BBS).
Limitations of Use
IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:
Other types of obesity not related to BBS or other FDA-approved indications for IMCIVREE, including obesity associated with other genetic syndromes and general (polygenic) obesity
WARNINGS AND PRECAUTIONS
Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.
Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.
Skin Pigmentation and Darkening of Pre-existing Nevi: Generalized increased skin pigmentation and darkening of pre-existing nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new 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. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved drugs.
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection
USE IN SPECIFIC POPULATIONS
Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at 833-789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
We use cookies to give you the best online experience and content. By using our website, you agree to our use of cookies in accordance with our cookie policy.