The U.S. Food and Drug Administration said on Wednesday it approved an injection for “double chin” reduction, developed by Kythera Biopharmaceuticals Inc.
The drug, Kybella, is a formulation of synthetically-derived deoxycholic acid, which destroys fat under the chin, leaving surrounding tissue largely unaffected.
Other injectables such as Allergan Inc’s Botox and other dermal fillers are typically used to smoothen areas of the face.
Fat removal involves more radical procedures – limited to surgeries performed under general anesthesia and liposuction – and higher costs.
Submental, or below the chin, liposuction costs between $2,700 and $5,175, according to the American Society for Dermatologic Surgery.
Kythera has not revealed its pricing plans for the injection.
The approval follows the unanimous backing of an independent panel of experts to the FDA in March.
Last year, Kythera regained the rights to market the drug outside the United States and Canada from a unit of Germany’s Bayer AG.
Westlake Village, California-based Kythera’s stock, which has risen about 37 percent this year, was marginally down at $47.45 in afternoon trading on the Nasdaq on Wednesday.
New dad given 2 hours to live after bike accident survives with heart pump implant
47-year-old Curtis Broome and his wife, Heather, set off on a 32-plus-mile bike ride along a route called The Three Bears in Northern California. While the couple had scheduled the ride in an attempt to play matchmaker for friends who had come along, about five miles into the trip Curtis began to fall behind.
He had been wearing a heart monitor for nearly nine months after a routine doctor’s visit showed he had high blood pressure, but was otherwise healthy. Heather, then 38, slowed her pace to make sure he was OK, and he said he was— until the two came to a descending portion of the route where they surpassed speeds of over 30 miles per hour for at least one mile. The rest of the group was farther ahead, and the pair got caught at a red light before they would need to hustle across the Highway 24 entrance.
“I went into a sprint, and that’s the last thing I remember,” Curtis told FoxNews.com, “and not until the Golden Gate Bridge. There’s nothing in between.”
First responders who arrived on the scene thought Curtis, who was on the ground with his body beat up and bruised, might have gotten hit by a car. Rather, he went into cardiogenic shock after his heart rate surpassed 200 beats per minute. When the Silicon Valley entrepreneur lost consciousness, he did a head-dive and fractured his eye socket, suffering contusions in the front part of his brain.
“I think he had a couple of hours to live,” Dr. Richard Chang, an interventional cardiologist at John Muir Medical Center in Walnut Creek, Calif., and of the Society for Cardiovascular Angiography Interventions (SCAI), told FoxNews.com. “Most patients who have sudden cardiac arrest outside the hospital— the statistics are less than 1 percent leave the hospital functional.”
‘He was lucky’
Man has 99 pounds of excess skin removed after dramatic weight loss
Once dubbed “The World’s Heaviest Man,” a British man has traveled to New York City to undergo surgery to remove 99 pounds of excess skin.
Paul Mason, 54, of Ipswich, England, suffered from an eating disorder, growing to 980 pounds before undergoing gastric bypass surgery in February 2010, according to his YouCaring fundraising page. Since then, Mason has lost over 600 pounds and changed his relationship with food.
However, his weight loss left him with roughly 100 pounds of loose skin, hindering his walking and ability to exercise to continue to lose weight. His goal weight is 200 pounds, but he relies on a wheelchair.
Mason moved to the United States after deciding that waiting for the National Health Service (NHS) to cover surgery— which could take years— was no longer an option.
According to The New York Times, after an article about Mason’s dramatic weight loss and struggle with his loose skin appeared in the newspaper, the mother of Dr. Jennifer Capla, a plastic surgeon from Lenox Hill Hospital in New York City, called her and told her daughter she had to help Mason.
Capla told Mason that if he was able to get to the U.S., she would offer her services for free. Mason was to cover his transportation, hospital fees and aftercare, all of which he is fund-raising for on his YouCaring page.
Mason was cleared for surgery on Tuesday and will need to stay in New York for up to four weeks.
“Paul is reaching out to those who are struggling with obesity and emotional addiction to food,” his website reads. “He wants to spread awareness that for some people, being overweight is not a simple issue with a simple solution. Overcoming the psychological desire to eat is a bigger hurtle (sic) than many can overcome, but with the proper understanding and with a desire to change, anyone can turn their life around.”