Product
Eylea
Approval Date
November 18, 2011
Release Date
November 22, 2012
Company
Regeneron
Class
Anti-VEGF therapy
Indication
For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD)
Active Ingredient
Aflibercept injection
Agency Roster
Stonefly Communications (digital)
WCG (PR)
Marketing Strategy/Execution
The launch strategy for Eylea includes a commercial team of over 125 people trained to educate retinal specialists in use of this new, more convenient option for treating macular degeneration. With the approval, Regeneron enters the same space as Genentech’s Lucentis (ranibizumab) and off-label Avastin (bevacizumab). The field force size is consistent with that of competitors and is sufficient to reach the 2,500 retinologists in the US who treat wet AMD, said Robert Terifay, Regeneron SVP, commercial. Regional directors average 15 years of biologic sales experience and have broad experience across ophthalmology, oncology and immunology. A spokesman said there will be no DTC campaign, as the “market can be efficiently addressed via the treating physicians, patient organizations, senior groups, etc.” Eylea is priced at $1,850 per injection, or $16,000/year, vs. $1,950 per injection, or $29,000/year, for monthly Lucentis. Like many biologics, Eylea will be bought and sold under a buy-and-bill scheme.
Physician Outlook
Wet AMD is the leading cause of blindness for people over the age of 65 in the US and Europe. The main advantage of EYLEA, a recently approved recombinant fusion protein over its competitor Lucentis (ranibizumab), appears to be less frequent intravitreal injections. An intravitreal injection is and uncomfortable and somewhat invasive procedure, where the drug is injected directly into the eyeball. EYLEA, dosed every eight weeks (following three initial monthly injections), was found to be clinically equivalent to the standard of care, Lucentis (also intravitraelly injected), which is given every four weeks. Reducing the frequency of administration will improve the quality of life for this patient population, and reduce their exposure to risk factors associated with intravitreal injection, as well as using less physician/hospital time to deliver the injections.
– Rishard Salie, PhD, project manager, research & consulting, GfK HealthCare, Dec. 2011
Also in the Pipeline (according to Adis R&D Insight)
Drug: AL 8309B
Manufacturer: Alcon
Indication: Age-related macular degeneration (dry form)
Active Ingredient:
Phase: III
Source: Wolters Kluwer Health, Dec. 2011
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.
