Raptiva risks outweigh benefits, E.U. regulators say
NEW YORK More bad news about a Genentech drug for treating psoriasis emerged Friday, this time from Europe.
The European Medicines Agency said that the risks of Raptiva (efalizumab) outweigh the benefits, and the agency has recommended that marketing of the drug be suspended in the European Union after a patient developed progressive multifocal leukoencephalopathy, or PML, a deadly brain infection.
The U.S. Food and Drug Administration had released a statement Thursday saying that three people taking Raptiva over the course of several years had developed PML and died, but did not recommend removing it from the market.
PML results from an opportunistic infection by the JC virus, causing irreversible decline in brain function and death in people with severely weakened immune systems. According to the National Institutes of Health, most people carry the JC virus, though it is harmless to those with healthy immune systems. Raptiva works by suppressing the immune system’s T-cells.
Merck Serono, a subsidiary of Germany-based Merck KGaA and a distinct company from U.S.-based Merck & Co., markets Raptiva in Europe.
Missouri legislator proposes moving PSE Rx-only
Issue: How do you stop meth addicts from circumventing current pseudoephedrine purchase restrictions by buying their respective PSE limits across several area pharmacies, a practice that’s been dubbed “group smurfing”? Answer: Create an electronic real-time logbook database so that law enforcement can catch these “smurfers” in the act.
Or, if you’re in Missouri, you can take the cost associated with creating such a database and shift that cost right onto the backs of your constituents, by requiring them to get a prescription for PSE first. That’s really what the Missouri legislator is proposing. Rep. Jeff Roorda, D-Barnhart, who sponsored the bill in the House, even said as much. The prescription requirement would prevent the state from "dumping money into a database that we don’t know will work,” he said, according to published reports.
The bigger issue is appropriate access to healthcare. Reverse-switching PSE limits that access — and forces consumers to go through the added hassle of making a doctor’s appointment, taking time off from work to see that doctor, and filling a prescription for PSE, all within the seven days the average cold lasts. To be sure, PSE isn’t the only cough-and-cold relieving ingredient in town. But while there are other options on the shelf, there are also consumers who are loyal to their PSE products. And it’s these consumers who would pay the price. And if not them, then their healthcare payors. How much more would it cost to treat a Medicaid recipient with prescription PSE versus maintaining their ability to buy that product from their pharmacist?
On the other hand, the electronic logbook solution — incidentally, Missouri lawmakers authorized a statewide electronic monitoring system for PSE-based drugs last year, it just hasn’t been funded yet — is not necessarily a panacea. The cost associated with becoming a part of such a database could be prohibitive, especially if that cost is actually borne by retailers. That cost is compounded for national retailers, who might have to conform to disparate systems across state lines. There is also a concern that pharmacy personnel might be placed in danger if they’re required to refuse a PSE sale because their customer reached their limit at the pharmacy down the street five minutes ago. Meth addicts, after all, aren’t the most law-abiding citizens and might be prone to violence.
Wyeth’s Conbriza recommended for EU approval
COLLEGEVILLE, Pa. The Committee for Medicinal Products for Human Use , the scientific committee of the European Medicines Agency, on Thursday adopted a positive opinion recommending to grant a marketing authorization for Conbriza (bazedoxifene) for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. Conbriza, an investigational medicine, is in development by Wyeth Pharmaceuticals.
“If approved, Wyeth believes that Conbriza could be an important new treatment option for physicians and their patients,” stated Gary Stiles, EVP and chief medical officer, Wyeth Pharmaceuticals. “More therapeutic options are needed for postmenopausal women with osteoporosis, particularly for those at increased risk of fracture. Wyeth remains committed to women’s health care, and Conbriza is an important affirmation of that commitment.”
The CHMP is responsible for reviewing medicinal product applications for safety, quality and efficacy. The Committee’s positive opinion will be forwarded to the European Commission for a final decision. Final approval customarily follows the CHMP’s recommendation and is expected in approximately 60 days.
Wyeth intends to introduce Conbriza in Europe following receipt of necessary reimbursement authorizations. Wyeth is also pursuing regulatory approval of bazedoxifene for the prevention and treatment of postmenopausal osteoporosis in the United States.