FDA approves J&J’s Xarelto for stroke prevention
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for preventing stroke in patients with abnormal heart rhythm, the agency said.
The agency announced Friday the approval of Xarelto (rivaroxaban), an anti-clotting made by J&J subsidiary Janssen Pharmaceuticals, in patients with non-valvular atrial fibrillation. The FDA approved the drug in the 10-mg strength in July for deep-vein thrombosis in patients receiving knee and hip replacement surgery. The latest approval includes 15-mg and 20-mg strengths.
Atrial fibrillation is one of the most common types of abnormal heart rhythm and affects more than 2 million people. The condition causes irregular and poorly coordinated beating of the heart’s two upper chambers, which leads to pooling and clotting of blood.
"Atrial fibrillation can lead to the formation of blood clots, which can travel to the brain, blocking blood flow and causing a disabling stroke," FDA Division of Cardiovascular and Renal Products director Normal Stockbridge said. "This approval gives doctors and patients another treatment option for a condition that must be managed carefully."
Walgreens joins Magic Johnson Foundation on Point Forward Day
LOS ANGELES — The Magic Johnson Foundation on Monday initiated Point Forward Day, marking 20 years to the date that Johnson announced his HIV status and subsequent retirement from the National Basketball Association.
In partnership with AIDS Healthcare Foundation, MJF will host free confidential testing events at retailers, including Walgreens in Chicago. At select locations, testing will include participation from government officials, dignitaries and athletes who will lead their communities by getting tested first at on site mobile units.
From 10 a.m. to 10 p.m. on Nov. 7, in partnership with Beyond Care and South Side Health Center, Walgreens will be providing 12 straight hours of free HIV screenings at their new flagship store at 75th and State. People who stop by during the day will be able to receive testing, counseling and will be entered into a raffle for valuable prizes, including Jay-Z tickets, Walgreens gift cards and a basketball signed by Magic Johnson to mark the occasion. Power 92 will be broadcasting from the Walgreens from 6 p.m. to 10 p.m. and the Soul 106.3 Van will be on hand from 3 p.m. to 5 p.m. to provide music and raffles.
Johnson has donated a signed basketball that will be raffled off to all participants who are screened that day. Other prizes will be awarded during the day including concert tickets and Walgreens $100 cash cards.
"Not only will the participants be able to take advantage of free HIV screenings, but our medical experts will also be available to provide immediate information on treatments and overall healthy living," Walgreens director of community affairs John Gremer said. "We look forward to partnering with the Magic Johnson Foundation to create more Walgreens Community Empowerment Centers in our own backyard."
Additionally, mobile testing units will be available across the United States, including Atlanta, Chicago, Dallas, Fort Lauderdale, Fla., Los Angeles, Miami, New Orleans, New York, San Antonio, Hampton, Va., Wilton Manors, Fla., Marrero, La. and Washington, D.C.
Point Forward Day is made possible through the generosity of its title sponsor, Wells Fargo, which has been a long time support of the Magic Johnson Foundation. Best Buy, Cisco, FedEx, Grockit, IBM, AEG and Walgreens will be providing additional local and national support through technical assistance, employee engagement and in-kind contributions.
Celebrities and athletes are joining the campaign through a social media initiative aimed at raising awareness about HIV/AIDS. Dwayne Wade, Ludacris, Justin Bieber, Kobe Bryant, Adrian Peterson, Pau Gasol, Paula Abdul, Steve Nash, Monique Coleman, Faith Evans, Blair Underwood and more are pledging their support through Facebook, Twitter and Tout and encouraging fans to get tested on Point Forward Day.
Branded generics offer new ways to reformulate drugs
In the classic “Arabian Nights” tale of Aladdin and his magic lamp, the evil sorcerer who made Aladdin retrieve the lamp containing the genie attempts to get it back by tricking Aladdin’s wife into giving it to him by roaming through the streets offering to trade “new lamps for old.”
Today, many drug makers are taking old drugs and turning them into new drugs, but there’s no sorcery here. Branded generics offer drug makers an opportunity to find new ways to formulate drugs that have lost patent protection and gone generic, and some are making quite a bundle in the process.
“It’s part of a movement to get out of the commodity part of the generics business,” IMS Health VP industry relations Doug Long told Drug Store News. “Branded generics is part of that, but also injectables, nasal and [dermatology drugs].”
“Commodity generics” are drugs that might have had a good run for the first company, winning approval for the generic version and getting 180 days in which to compete directly against the branded manufacturer, but have since seen a huge reduction in price due to the market entry of companies that sometimes number in the dozens.
By contrast, IMS defines branded generics as either novel dosage forms of drugs that have lost patent protection and were not developed by the company marketing the branded generic, or simply as a generic drug that’s given a trade name. Well-known drugs that fall into the first category are Purdue Pharma’s OxyContin, an extended- release formulation of the generic opioid oxycodone, or Johnson & Johnson’s attention-deficit hyperactivity disorder drug Concerta (methylphenidate), which uses the same active ingredient as Novartis’ Ritalin, originally approved by the Food and Drug Administration in 1955. According to IMS, OxyContin ranks as one of the top-selling drugs in the country, with 2010 sales of $3.1 billion.
Many drugs in the second category are generic contraceptives, such as Teva Pharmaceutical Industries’ Camrese (levonorgestrel and ethinyl estradiol tablets), which is a generic version of Duramed Pharmaceuticals’ Seasonique, of which Watson Pharmaceuticals also makes a generic version under the brand name Amethia. The reasons why Teva, Watson and others adopt brand names for these drugs: The generic names are simply too much of a mouthful.
“If you didn’t invent the product, you could come up with a superior delivery system like OxyContin,” Long said. “That could certainly be quite lucrative.”
FDA regulations treat branded generics as branded drugs. For example, when Purdue Pharma filed for regulatory approval of OxyContin, it filed a new drug application; FDA approval entitles a branded generic to five years’ market exclusivity, but with less patent protection than there is for a newly developed molecule. By contrast, a company making a generic immediate-release formulation of oxycodone would use an abbreviated new drug application.
Branded generics appear to be one example of a broader industry move in recent years toward what might be termed “value-added generics,” which could also include knockoffs of difficult-to-make drugs like Sanofi’s blood-thinning drug Lovenox (enoxaparin sodium) and Teva’s multiple sclerosis treatment Copaxone (glatiramer acetate) and, thanks to provisions in the Affordable Care Act, follow-on biologics.
“Now you have other people trying to get into the market where there are higher barriers to entry. It’s a little less competitive, and there’s a chance to get higher profit margins,” Long said.