Results With AMVUTTRA

Steve, treated with AMVUTTRA®
Steve, treated with AMVUTTRA®

“After a discussion with my doctor, I thought AMVUTTRA® would be the best treatment for me.”

—STEVE, treated with AMVUTTRA
How did AMVUTTRA® help patients in the study?

Patients treated with AMVUTTRA showed significant improvement in nerve function and quality of life at 9 months, and continued to improve throughout an 18-month study of 164 adult patients, compared with those who received placebo in a similar study.

Nerve function

Quality of Life/p>

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Amvuttra v Placebo

At 9 months, AMVUTTRA significantly improved nerve function while patients who received placebo got worse.

At 18 months, 48% of patients who received AMVUTTRA regained some nerve function from the start of treatment compared with 4% of those who received placebo.

  • For the patients who received AMVUTTRA and did not regain some nerve function, progression of their neuropathy was slowed compared with those who received placebo

Nerve function was assessed using a scale called mNIS+7 that measured strength and sensation in the hands, feet, arms, and legs; reflexes; and blood pressure upon standing.

Amvuttra v Placebo

At 9 months, AMVUTTRA significantly improved quality of life while patients who received placebo got worse.

At 18 months, 57% of patients who received AMVUTTRA reported better quality of life from the start of treatment, compared with 10% of those who received placebo.

Quality of life was evaluated by the Norfolk QoL-DN questionnaire that asked patients about the severity of their polyneuropathy symptoms, how often they experienced them, and what impact they felt they had on their daily lives.

What other improvements did patients experience?

The effects of AMVUTTRA on other aspects of the disease, including walking speed, nutritional health, and ability to perform activities of daily living, were also evaluated after 18 months and compared with the effects of placebo in a similar study.

Patients treated with AMVUTTRA maintained a better walking speed, compared with patients who received placebo

  • Evaluated using the 10-meter walk test, a stopwatch-timed measure of a patient’s walking speed over 10 meters

Patients treated with AMVUTTRA improved in nutritional health after the first dose, compared with patients who received placebo

  • Evaluated using modified body mass index, an assessment of height, weight, and the balance of fluids in the body, and was maintained with continued dosing at 18 months

Patients treated with AMVUTTRA were better able to perform common daily activities compared with patients who received placebo

  • Evaluated using a questionnaire called R-ODS to assess ability to perform activities
  • Common daily activities included:
Showering, brushing teeth, dressing upper body, going shopping, doing the dishes, walking up a flight of stairs

 

Perform daily activities, like showering, brushing teeth, dressing upper body, going shopping, doing the dishes, walking up a flight of stairs

Important Safety Information and Indication

Important Safety Information

What are the most important things I should know about AMVUTTRA® (vutrisiran)?

AMVUTTRA can cause:

  • Low Vitamin A Levels

    Treatment with AMVUTTRA lowers the amount of vitamin A in your blood. Your doctor will tell you to take a vitamin A supplement every day. You should not take more than the amount of vitamin A recommended by your doctor.

    Low vitamin A levels can affect vision. If you have problems with your vision (e.g., night blindness) while taking AMVUTTRA, talk to your doctor. Your doctor may refer you to an eye specialist.

 

What are the common side effects of AMVUTTRA?

The most common side effects of AMVUTTRA are pain in the arms or legs, pain in the joints (arthralgia), shortness of breath (dyspnea), and low vitamin A levels.

These are not all the possible side effects of AMVUTTRA. Talk to your doctor about side effects that you experience. You are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration (FDA). Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indication

What is AMVUTTRA?

AMVUTTRA is a prescription medicine that treats the polyneuropathy caused by an illness called hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). AMVUTTRA is used in adults only.

For additional information about AMVUTTRA, please see the full Prescribing Information.