Genentech has done an about-face on its decision to limit the supply of Avastin (bevacizumab) to prevent its off-label use in treating age-related macular degeneration.

As the result of an agreement between the company, the American Academy of Ophthalmology (AAO) and the American Society of Retinal Specialists (ASRS), Genentech says it will allow physicians to prescribe Avastin and purchase it directly from authorized wholesale distributors. Wholesalers can then ship the drug to the destination of the physicians choice, including hospital pharmacies, compounding pharmacies, or directly to the physicians office.

In October, Genentech announced that it would no longer allow compounding pharmacies to purchase Avastin directly from wholesalers after January 1.

In an open letter to the retinal community, Susan Desmond-Hellman, M.D., M.P.H., Genentechs president of product development, cited several events, including the approval of its drug Lucentis (ranibizumab) specifically for AMD, plus concerns raised by the FDA about the sterility and repackaging of Avastin for ocular use, as reasons for its decision. This prompted an outcry in the medical community.

Lucentis and Avastin each bind to and inhibit all forms of VEGF-A. Avastin, which is FDA-approved for treating certain types of cancer, has been used off-label for treating neovascular AMDbut at a much lower cost than Lucentis, which was specifically made and FDA approved for treating AMD.

A single injection of Lucentis costs about $2,000, while a single injection of Avastin costs less than $100.

Genentechs move to limit the availability of Avastin prompted U.S. Sen. Herb Kohl (D-Wis), chairman of the Special Committee on Aging, to launch an investigation into the circumstances behind the companys decision.

Genentech continues to believe Lucentis is the most appropriate treatment for patients with wet age-related macular degeneration because it was specifically designed, formally studied, approved by the U.S. Food and Drug Administration, and manufactured for intraocular delivery for the treatment of wet AMD, the company said in a written statement announcing its agreement with the AAO and ASRS. At the same time, Genentech does not interfere with physicians prescribing choices, and believes that physicians should be able to prescribe the treatment they believe is most appropriate for their patients.

Vol. No: 145:01Issue: 1/15/2008