How was IMCIVREE studied?

IMCIVREE was evaluated across three, first-ever Phase 3 clinical trials dedicated to obesity and hunger reduction in people with POMC, PCSK1, or LEPR deficiency

STUDY 1

Children & adults 6 years and older with obesity due to
POMC or PCSK1
deficiency

10
participants

Results after
1 year

STUDY 2

Children & adults 6 years and older with obesity due to
LEPR
deficiency

11
participants

Results after
1 year

STUDY 3

Young children ages 2 to less than 6 years old with obesity due to
POMC, PCSK1, or LEPR
deficiency*

7
participants

Results after
1 year

In the clinical studies

Adults had a body mass index (BMI) of 30 kg/m2 or more. Children ages 6 to less than 18 years old had weight in the 95th percentile or higher using growth chart assessments. Young children ages 2 to less than 6 years old had weight in the 97th percentile or higher.

Study design

IMCIVREE was evaluated in 28 individuals (10 from Study 1, 11 from Study 2, and 7 from Study 3) who completed at least 1 year of treatment.

IMCIVREE clinical study

There were 6 additional participants who had not yet completed 1 year of treatment when this information was collected. Their results were not included in efficacy information, but are included in safety information.

Both Studies 1 and 2 included a period of time taking IMCIVREE, followed by a withdrawal period of 8 weeks, which included 4 weeks of IMCIVREE followed by 4 weeks of no treatment. Neither the investigators nor the participants were aware of when the 4-week non-treatment time period was occurring.

After the withdrawal period, participants went on to receive up to 32 additional weeks of treatment with IMCIVREE.

In Study 3, all participants received IMCIVREE and were observed over a 52-week period.

*Patients with PCSK1 deficiency were eligible but none enrolled in the trial.

See how IMCIVREE helped reduce
measures of weight and hunger

WHAT IS IMCIVREE?

IMCIVREE is a prescription medicine used in adults and children 2 years of age and older with obesity due to the genetic conditions pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency, to help them lose weight and keep the weight off.

Your healthcare provider should order an FDA-approved test to confirm POMC, PCSK1, or LEPR deficiency before you start using IMCIVREE.

IMCIVREE is not for use in people with the following conditions because it may not work:

  • Obesity due to suspected POMC, PCSK1, or LEPR deficiency not confirmed by genetic testing or with benign or likely benign genetic testing results
  • Other types of obesity not related to POMC, PCSK1, or LEPR deficiency, or other FDA-approved uses of IMCIVREE, including obesity associated with other genetic conditions and general obesity

It is not known if IMCIVREE is safe and effective in children under 2 years of age.

IMPORTANT SAFETY INFORMATION

Do not use IMCIVREE if you have had a serious allergic reaction to it or any of its ingredients. Serious allergic reactions, including anaphylaxis, can happen.

Before you use IMCIVREE, tell your healthcare provider about all your medical conditions, including if you:

  • Have or have had areas of darkened skin, including skin discoloration (hyperpigmentation)
  • Have or have had depression, or suicidal thoughts or behavior
  • Have kidney problems
  • Are pregnant or planning to become pregnant. Losing weight while pregnant may harm your unborn baby. Your healthcare provider may stop your treatment with IMCIVREE if you become pregnant. Tell your healthcare provider if you become pregnant or think you might be pregnant during treatment with IMCIVREE
  • Are breastfeeding or plan to breastfeed. It is not known if IMCIVREE passes into your breast milk. You should not breastfeed during treatment with IMCIVREE

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

See the detailed Instructions for Use that come with your IMCIVREE to learn how to prepare and inject IMCIVREE, and how to properly throw away (dispose of) used syringes and needles.

What are the possible side effects of IMCIVREE?
IMCIVREE may cause serious side effects, including:

  • Male and female sexual function problems. IMCIVREE can cause an erection that happens without any sexual activity in males (spontaneous penile erection) and unwanted sexual reactions (changes in sexual arousal that happen without any sexual activity) in females. If you have an erection lasting longer than 4 hours, get emergency medical help right away
  • Depression and suicidal thoughts or actions. You or a caregiver should call your healthcare provider right away if you have any new or worsening symptoms of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior
  • Serious allergic reactions. Stop taking IMCIVREE and get medical help right away if you have any symptoms of a serious allergic reaction including: swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; rapid heartbeat
  • Increased skin pigmentation, darkening of skin lesions (moles or nevi) you already have, and development of new skin lesions. These changes happen because of how IMCIVREE works in the body and will go away when you stop using IMCIVREE. You should have a full body skin exam before starting and during treatment with IMCIVREE to check for skin changes
  • Benzyl alcohol toxicity. Benzyl alcohol is a preservative in IMCIVREE. Benzyl alcohol can cause serious side effects, including death, in premature and low-birth weight infants who have received medicines that contain benzyl alcohol. IMCIVREE should not be used in premature and low-birth weight infants

The most common side effects of IMCIVREE include darkening of the skin, injection site reactions, nausea, headache, diarrhea, stomach pain, vomiting, depression, and an erection that happens without any sexual activity in males.

These are not all the possible side effects of IMCIVREE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call FDA at 1-800-FDA-1088.

Please see full prescribing information, including Patient Information.

Important Safety Information

WHAT IS IMCIVREE?

IMCIVREE is a prescription medicine used in adults and children 2 years of age and older with obesity due to the genetic conditions pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency, to help them lose weight and keep the weight off.

Your healthcare provider should order an FDA-approved test to confirm POMC, PCSK1, or LEPR deficiency before you start using IMCIVREE.

IMCIVREE is not for use in people with the following conditions because it may not work:

  • Obesity due to suspected POMC, PCSK1, or LEPR deficiency not confirmed by genetic testing or with benign or likely benign genetic testing results
  • Other types of obesity not related to POMC, PCSK1, or LEPR deficiency, or other FDA-approved uses of IMCIVREE, including obesity associated with other genetic conditions and general obesity

It is not known if IMCIVREE is safe and effective in children under 2 years of age.

IMPORTANT SAFETY INFORMATION

Do not use IMCIVREE if you have had a serious allergic reaction to it or any of its ingredients. Serious allergic reactions, including anaphylaxis, can happen.

Before you use IMCIVREE, tell your healthcare provider about all your medical conditions, including if you:

  • Have or have had areas of darkened skin, including skin discoloration (hyperpigmentation)
  • Have or have had depression, or suicidal thoughts or behavior
  • Have kidney problems
  • Are pregnant or planning to become pregnant. Losing weight while pregnant may harm your unborn baby. Your healthcare provider may stop your treatment with IMCIVREE if you become pregnant. Tell your healthcare provider if you become pregnant or think you might be pregnant during treatment with IMCIVREE
  • Are breastfeeding or plan to breastfeed. It is not known if IMCIVREE passes into your breast milk. You should not breastfeed during treatment with IMCIVREE

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

See the detailed Instructions for Use that come with your IMCIVREE to learn how to prepare and inject IMCIVREE, and how to properly throw away (dispose of) used syringes and needles.

What are the possible side effects of IMCIVREE?
IMCIVREE may cause serious side effects, including:

  • Male and female sexual function problems. IMCIVREE can cause an erection that happens without any sexual activity in males (spontaneous penile erection) and unwanted sexual reactions (changes in sexual arousal that happen without any sexual activity) in females. If you have an erection lasting longer than 4 hours, get emergency medical help right away
  • Depression and suicidal thoughts or actions. You or a caregiver should call your healthcare provider right away if you have any new or worsening symptoms of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior
  • Serious allergic reactions. Stop taking IMCIVREE and get medical help right away if you have any symptoms of a serious allergic reaction including: swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; rapid heartbeat
  • Increased skin pigmentation, darkening of skin lesions (moles or nevi) you already have, and development of new skin lesions. These changes happen because of how IMCIVREE works in the body and will go away when you stop using IMCIVREE. You should have a full body skin exam before starting and during treatment with IMCIVREE to check for skin changes
  • Benzyl alcohol toxicity. Benzyl alcohol is a preservative in IMCIVREE. Benzyl alcohol can cause serious side effects, including death, in premature and low-birth weight infants who have received medicines that contain benzyl alcohol. IMCIVREE should not be used in premature and low-birth weight infants

The most common side effects of IMCIVREE include darkening of the skin, injection site reactions, nausea, headache, diarrhea, stomach pain, vomiting, depression, and an erection that happens without any sexual activity in males.

These are not all the possible side effects of IMCIVREE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call FDA at 1-800-FDA-1088.

Please see full prescribing information, including Patient Information.