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Will Your Macular Degeneration Drug Disappear?
The drug Lucentis is FDA approved for treatment of advanced ARMD patients. It is injected every month or so and it is very expensive. Guess what? There is a very similar injectable compound available as cancer chemotherapy - it's called Avastin. Using Avastin to treat ARMD is much cheaper but head-to-head comparison studies have never been performed. Nevertheless, many ophthalmologists offer Avastin to the ARMD patients as "off-label use".
To learn more about injectable therapies for ARMD, please read one of my earlier posts on this subject.
Genentech makes both Avastin and Lucentis, and it loses money every time the cheaper drug is used. Accordingly, Genentech is outlawing the sale of Avastin to compounding pharmacists who reconstitute Avastin for intraocular injection. As expected, there has been a fierce backlash by ophthalmologists.
Here is an excerpt from a press release issued by the American Academy of Ophthalmology:
The American Academy of Ophthalmology believes that Genentech's decision to stop sales of Avastin® (bevacizumab) to compounding pharmacies could have a significant impact on the care of patients with age-related macular degeneration (AMD).
"Our main concern is for our patients with macular degeneration, who have come to rely on Avastin in their fight against potential vision loss," said Charles "Pat" Wilkinson, MD, president of the Academy. "Together with the retinal community, the Academy is evaluating how this decision will affect patient care."
Both Avastin and the FDA-approved Lucentis® (ranibizumab injection), another drug sold by Genentech, share a similar method of action by inhibiting vascular endothelial growth factor (VEGF). However, Lucentis was designed and tested specifically for treatment of wet AMD, while Avastin has only been FDA-approved for oncology indications. Prior to Lucentis' approval, many ophthalmologists had been using Avastin to treat wet AMD, and many doctors continue to use it, citing good clinical results for patients. The National Institute of Health is sponsoring a head-to-head trial between the two drugs starting this year.
"The primary concern of ophthalmologists is preserving the sight of our patients. Because Avastin has also been used off-label to treat diabetic retinopathy, macular edema and various other sight-threatening disorders, Genentech's decision to restrict availability of the drug has much wider implications than just for AMD patients," said H. Dunbar Hoskins Jr., MD, executive vice president of the Academy.
The Academy is seeking information from the FDA and Genentech to determine an appropriate and safe solution for patients and their doctors.
According to Genentech, Avastin will continue to be made available directly to physicians and hospital pharmacies through authorized wholesale distributors. However, ophthalmologists need compounding pharmacies to divide vials of Avastin into smaller doses for the treatment of AMD and other eye disorders.
Bottom line: Clinicians do not want to be told how to practice medicine, not by government and certainly not by drug companies.
You can expect to hear more about this in the days ahead.
Related Topics: Technorati Tags: macular degeneration, medication, Avastin, Lucentis, vision
