CAMZYOS® Gets Results
CAMZYOS is approved for adults and children weighing at least 66 lbs (30 kg) or more. It is not known if CAMZYOS is safe and effective in children under 66 lbs. Individual results may vary.
Actor portrayals.
First-in-Class* Treatment. Proven in Clinical Studies.
Explore clinical study data for: Symptom Improvement | Obstruction Reduction | Long-Term Results | Reducing Surgical Eligibility | Children Ages 12-17
Helps improve symptoms† and the ability to be active‡
In a 30-week study, more adults who took CAMZYOS were able to be more active compared with those who did not take it, and they saw their symptoms get better§ or stop getting worse.‖
Twice as many people taking CAMZYOS achieved this outcome (37%) compared with those taking placebo (17%).
*CAMZYOS is a cardiac myosin inhibitor.
†Symptoms were measured using the New York Heart Association, or NYHA, classification.
‡The ability to be active was determined by measuring peak oxygen consumption, or pVO2, which is the maximum amount of oxygen the body uses during exercise. This was measured during exercise testing on a bicycle or treadmill.
§Symptoms getting better or improving was defined as improvement in NYHA class.
‖In the CAMZYOS group at Week 30, 50% of adults were in NYHA Class 1, 42% were Class 2, and 7% Class 3. In the placebo group at Week 30, 21% of adults were in NYHA Class 1, 58% were Class 2, and 20% Class 3.
Reduced obstruction in the heart
CAMZYOS reduced obstruction in the heart 4X more vs those who did not take CAMZYOS at 30 weeks.
In a clinical study comparing CAMZYOS vs placebo in adults, after 30 weeks, obstruction (measured by post-exercise LVOT gradient) decreased on average 47 mm Hg (started at 86 mm Hg and went down to 38) and for placebo decreased on average 10 mm Hg (started at 84 mm Hg and went down to 73).
LVOT=left ventricular outflow tract.
In a different study (long-term, 252 weeks), there was an 80% average decrease in obstruction.
The 184 adults who completed the study and took CAMZYOS had an average reduction in LVOT gradient from 70 mm Hg to 14 mm Hg at approximately 5 years. This represented an average decrease of LVOT gradient of 56 mm Hg. The average patient’s Valsalva LVOT gradient was under 30 mm Hg, meaning no longer obstructed (obstruction defined as LVOT gradient ≥30 mm Hg).
This information is not in the CAMZYOS Prescribing Information. It reflects observations made during treatment, not results from a study designed to test them, so it should be weighed alongside all other information about CAMZYOS. Ask your doctor what it means for you.
In oHCM, how is obstruction measured?
In oHCM, doctors use a heart ultrasound (echocardiogram) to check for obstruction of blood flow as it leaves the heart. The ultrasound measures the pressure difference across the obstruction as blood flows out of the heart.
Talk to your doctor to determine if a stress test (known as a Valsalva maneuver) is right for you to challenge the heart and help reveal potential obstruction.
What does your number mean?
Why is reducing obstruction important?
In hearts with obstructive HCM, an obstruction can block oxygen-rich blood from being pumped throughout the body, which can lead to symptoms. CAMZYOS can help reduce the obstruction.
HCM=hypertrophic cardiomyopathy; mm Hg=millimeters of mercury.
Most patients were symptom-free¶ at 5 years
About 3 out of 5 adults# had no symptoms or limitations with ordinary physical activity (defined as NYHA Class 1; 59%, 109/184) at 5 years.
2 studies illustrate symptom improvement:
Long-Term Study: About 2 out of 3 people# taking CAMZYOS had improved symptoms at 5 years (70%). 128 out of 184 people on CAMZYOS experienced improved symptoms at 5 years. Additionally, 1 out of 3 people had mild symptoms and some exercise limitations – defined as NYHA Class 2. (This was 39% of people, or 72 out of 184.) Out of the 184 adults who reached Week 252, the remaining 3 had noticeable symptoms with minimal physical activity (NYHA Class 3).
This information is not in the CAMZYOS Prescribing Information. It reflects observations made during treatment, not results from a study designed to test them, so it should be weighed alongside all other information about CAMZYOS. Ask your doctor what it means for you. See more details below.
How was this measured? Symptom improvement was defined as moving to a lower NYHA class in the study.
Primary Study: About 2 out of 3 adults taking CAMZYOS had their symptoms improve at 30 weeks. 65% of people taking CAMZYOS improved by one or more NYHA class. (31% of people taking placebo did the same.) 80 out of 123 patients on CAMZYOS experienced improved symptoms, compared with 40 out of 128 patients on placebo, at 30 weeks.
¶Symptom-free is defined as NYHA Class 1.
#184 adults to date (of 231) have reached Week 252 for evaluation.
Reduced eligibility for surgery
CAMZYOS reduced the number of adults who were eligible for surgery or who chose to undergo surgery at 16 weeks vs those who did not take it.
4 out of 5 people (82%) who took CAMZYOS improved in their symptomatic oHCM and were no longer eligible for and did not proceed with surgery at 16 weeks, vs 1 out of 5 people who took placebo.
About 1 out of 5 people taking CAMZYOS—18%, or 10/56—were still considered eligible for surgery at 16 weeks or had chosen to undergo surgery by Week 16. In contrast, 77% of patients on placebo (43/56) were still eligible for surgery at 16 weeks or decided to proceed with surgery. Two people in each group decided to have surgery.
CAMZYOS will not work for everyone. Individual results may vary. Your doctor will be able to advise you on whether CAMZYOS is right for you.
Now approved for children and teens weighing at least 66 lbs (30 kg) or more
CAMZYOS is the only FDA-approved treatment of its kind** proven to reduce obstruction in children and teens with symptomatic oHCM.
In a clinical study, children and teens taking CAMZYOS experienced a significant reduction in heart obstruction, helping blood flow out of the heart, at Week 28 compared to those taking placebo. At 28 weeks, CAMZYOS reduced obstruction (as measured by Valsalva LVOT gradient) on average 49 mm Hg vs 2 mm Hg for placebo.
How was this measured?
Reduced obstruction was defined as a reduction in the Valsalva LVOT gradient.
The above information is not in the CAMZYOS Prescribing Information. It reflects observations made during treatment, not results from a study designed to test them, so it should be weighed alongside all other information about CAMZYOS. Ask your doctor what it means for you.
In the pediatric study, no new side effects were identified compared with adult studies. The most common side effects of CAMZYOS include dizziness and fainting.
**CAMZYOS is a cardiac myosin inhibitor.
††Resting or Valsalva LVOT gradient of ≥30 mm Hg is considered obstruction.
Learn more about the studies, including the side effects below.
Who took part?
251 people with symptomatic oHCM—123 were treated with CAMZYOS and 128 with placebo for 30 weeks.
Though it wasn’t a requirement, most people (92%) remained on their previous medication, a beta-blocker or calcium channel blocker.
What did the study look at?
How well CAMZYOS was able to improve symptoms and the ability to be active.
Patients could achieve either less symptoms (improvement in NYHA Class) and improved pVO2 by at least 1.5 mL/kg/min OR symptoms remaining the same and improved pVO2 by at least 3.0 mL/kg/min.
Who took part?
231 people continuing from Study 1. They all received CAMZYOS. Though it wasn’t a requirement, most people (93%) have remained on their previous medication, a beta-blocker or calcium channel blocker.
When did Study 2 begin?
When Study 1 ended, people paused taking CAMZYOS for at least 8 weeks before starting Study 2.
How long did it last?
5 years, or 252 weeks.
What did the study look at?
First, to evaluate the safety of CAMZYOS, and then, to understand the efficacy.
Important limitations to know
This information is not in the CAMZYOS Prescribing Information. It reflects observations made during treatment, not results from a study designed to test them, so it should be weighed alongside all other information about CAMZYOS. Ask your doctor what it means for you.
Who took part?
112 people with symptomatic oHCM; 56 were treated with CAMZYOS and 56 with placebo for 16 weeks.
When the study started, everyone had symptoms. Their oHCM was so advanced that they were all eligible for surgery. Most (93%) had severe symptoms (NYHA Class 3 or 4). Most people (95%) were also taking additional treatments for oHCM, such as beta-blockers, calcium channel blockers, disopyramide, or a combination.
What did the study look at?
How many people remained eligible for, or who decided to proceed with, surgery prior to or at Week 16.
Who took part?
The study compared 44 pediatric patients ages 12-17 taking CAMZYOS (23 patients) vs those taking placebo (21 patients). Though it isn’t a requirement, most patients were on previous medications for symptomatic oHCM at baseline: beta-blocker (84%), calcium channel blocker (11%), disopyramide (20%), or combinations.
What does the study look at?
How well CAMZYOS was able to improve obstruction for people ages 12-17 with oHCM. The main goal was to measure how much the pressure blocking blood flow out of the heart changed after the Valsalva maneuver at 28 weeks.
Side Effects
If you and your doctor are considering CAMZYOS, it’s important to know the answers to these questions:
What are the serious side effects of CAMZYOS?
A serious side effect is a side effect that can sometimes be life-threatening and lead to death.
CAMZYOS may cause serious side effects, including heart failure (a condition where the heart cannot pump with enough force).
In the long-term study, 12 (5.2%) adults in the study experienced drug-related serious adverse events, which included ejection fraction decreased (5 patients), cardiac failure (4 patients), atrial fibrillation (1 patient), atrial flutter (1 patient), and ventricular dysfunction (1 patient).
Get medical help right away if you experience new or worsening symptoms, including:
- Shortness of breath
- Chest pain
- Fatigue
- Racing heart (palpitations)
- Leg swelling
- Rapid weight gain
What are the most common side effects?
The most common side effects of CAMZYOS include dizziness and fainting (syncope).
In the long-term study, 177 (76.6%) adults experienced ≥1 adverse events of clinical interest. The most common adverse events of clinical interest occurring in >5% of adults were atrial fibrillation (37 patients), ejection fraction decreased (16 patients), and cardiac failure (13 patients).
- Tell your healthcare provider if you have any side effect that bothers you or that does not go away
- These are not all of the possible side effects of CAMZYOS
- Talk to your healthcare provider for more information about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Bristol Myers Squibb at 1-800-721-5072
For more information, please see the U.S. Full Prescribing Information, including Boxed WARNING and Medication Guide for CAMZYOS. Talk to your healthcare provider for more information about this medication.