More than three long years after Orexigen was turned back at the FDA and forced to do a costly late-stage safety study of its weight drug Contrave, the agency has come back and given its seal of marketing approval to the drug.
ReShape Medical revealed the first postapproval data from the EU for its nonsurgical, balloon-based weight-loss system: 42% of excess weight loss on average with a variance of 23%. But the company cautions that because of the different way the trials are designed, it won't have similar results when it releases pivotal U.S. trial data in November.
Investigators at The Scripps Research Institute discovered a signaling pathway that switches on a calorie-burning phenomenon in cells.
USGI Medical, a California-based devicemaker focused on incisionless, endoscopic procedures for weight loss, reflux and advanced therapeutic endoscopy, said enrollment has been completed for a pivotal study to evaluate the company's POSE (Primary Obesity Surgery, Endolumenal) procedure.
There has been no new medical device to treat obesity approved by the FDA in more than a decade. A series of companies are hoping to be the first, including ReShape Medical, which has filed a PMA with FDA for its ReShape Integrated Dual Balloon System aimed at weight loss for the obese with a body mass index from 30 to 40.
An implantable device to treat morbid obesity with vagal nerve blocking therapy will be considered by the FDA's Gastroenterology-Urology Devices panel on June 17. Its chances going into the meeting don't look great: The panel documents point out that it didn't meet either of its primary efficacy endpoints and the panel date was already delayed once in March. Still, while the 12-month data aren't good, at 18 months the device looks a bit more promising.
Orexigen had to wait three long years to take a second shot at an approval for its weight drug NB32, earlier called Contrave. Now it gets to wait another three months for an FDA marketing decision as they talk through a regulatory requirement on tracking cardiovascular outcomes among people taking the therapy.
If Orexigen wins FDA approval for its new weight loss drug, how will it and its pharma partner Takeda take on the obesity market?
If Orexigen wins FDA approval for its weight loss drug NB32 (which used to be called Contrave) by tomorrow's long-awaited PDUFA date--and the odds are in its favor--look for the biotech and its pharma partner Takeda to barrel into a huge obesity market that has provided a chilly reception for a pair of rivals.
Boston startup Gelesis has picked up $12 million in venture funding, cash that'll support its novel approach to obesity treatment: a pill that disperses expanding particles in the gut to make patients feel full.