Product
Lumizyme
Approval Date
May 24, 2010
Release Date
May 24, 2010
Company
Genzyme
Class
Lysosomal glycogen-specific enzyme
Indication
For the treatment of patients ≥8 years of age with late (non-infantile) onset Pompe disease (acid α-glucosidase (GAA) deficiency) who do not have evidence of cardiac hypertrophy.
Active Ingredient
Alglucosidase alfa
Agency Roster
Core-Create (patient education)
Marketing Strategy/Execution
As the first product approved to treat late-onset Pompe disease, Lumizyme addresses an unmet need, and this is just one message being stressed in marketing. Pompe disease leads to severe muscle weakness, and promotional points emphasize the enzyme therapy’s capacity to impact walking ability in these patients and to improve their respiratory function. Only one in 40,000 people worldwide are affected by this rare but debilitating condition, which results from a missing enzyme in cells that breaks down glycogen. To stimulate new patient growth, Genzyme is using non-branded ads on WebMD and direct mail. Neither print nor TV ads are in the works, the company told MM&M. But Hollywood created some buzz when the search for a cure for Pompe disease was dramatized in the 2010 film Extraordinary Measures, starring Harrison Ford.
Also in the Pipeline (courtesy of Adis R&D Insight)
No competitor compounds in Phase III or pre-registration, US
Source: Wolters Kluwer Pharma Solutions
Pharmacology
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Clinical Trials
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adverse Reactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adults
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Children
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Precautions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Contradictions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
