VIMIZIM® (elosulfase alfa) can provide long-lasting benefits
A 120-week extension study showed that the benefits of VIMIZIM® (elosulfase alfa) can be maintained over the long term and are consistent with the results of the primary study.
In the 2-year extension study (MOR-005), all patients transitioned over time to receive VIMIZIM as a once-weekly treatment. The results of the treated patient group could not be compared to placebo since the study did not include a placebo group.
Results from the long-term extension study showed a 32.9-meter mean increase in the 6-minute walk test (6MWT) compared to baseline.
Helped lungs work better
Breathing function as measured by pulmonary function tests improved for patients in the long-term extension study compared to baseline.
FVC, volume of air that can forcibly be exhaled from the lungs after taking the deepest breath possible
FEV1, maximum volume of air that can be forcibly blown out in 1 second.
The most common side effects reported during VIMIZIM infusions included fever, vomiting, headache, nausea, abdominal pain, chills, and fatigue. These are not all of the possible side effects with VIMIZIM. Talk to your doctor if you have any symptoms that bother you or that do not go away.
Serious and severe reactions were associated with VIMIZIM® (elosulfase alfa), including hypersensitivity reactions and life-threatening allergic reactions (anaphylaxis).
In clinical trials, 18.7% of patients treated with VIMIZIM experienced hypersensitivity reactions and 7.7% experienced anaphylaxis.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.