FDA Approves Two New Drugs for Glaucoma
The FDA Friday approved two new glaucoma drugs, one of which has been shown to have "greater effectiveness for black patients," who are disproportionately affected by the disease. Reuters reports that the drug maker Alcon, a division of Nestle, said that Travatan, while approved for all individuals, is the first glaucoma treatment that especially helps black patients, who are "four times more likely than others to have glaucoma and [are] at higher risk for going blind from the disease" (Richwine, Reuters, 3/16). The second drug approved Friday is Allergan Inc.'s Lumigan, which, along with Travatan, will compete against Pharmacia Corp.'s Xalatan, the current top-selling drug for the disease, which affects roughly three million Americans (Los Angeles Times, 3/17). The "standard first-line therapy" is timolol, but this drug has "numerous side effects" and cannot be used by people with heart or respiratory problems (Neergaard, Associated Press, 3/16).
In announcing the approvals, the FDA said, "The availability of multiple medical alternatives provides physicians with additional treatment options for their patients whose glaucoma is difficult to manage." Bloomberg News/Detroit News reports that the FDA approval sets up a "marketing battle" between Xalatan and Lumigan that is likely to begin in court. After Lumigan's approval was announced, Pharmacia released a statement saying that the new drug "violates at least two of its Xalatan patents." Allergen said that earlier this month it filed a lawsuit asking a U.S. District Court in Delaware to declare that Lumigan does not infringe on Xalatan's patents and that the patents are "invalid" (Reed, Bloomberg News/Detroit News, 3/17).