Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA

• Approval based on Phase III NAPOLI 3 clinical trial in which Onivyde® regimen (NALIRIFOX) demonstrated statistically significant superiority and clinically meaningful improvements in overall survival and progression-free survival versus nab-paclitaxel and gemcitabine
• NAPOLI 3 represents the first positive Phase III trial in first-line metastatic pancreatic adenocarcinoma (mPDAC) to demonstrate superior overall survival versus the currently approved regimen of nab-paclitaxel and gemcitabine
• Onivyde is the only FDA-approved treatment regimen to demonstrate efficacy in two Phase III trials across lines of therapy in mPDAC

PARIS, FRANCE, 13 February 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.

“The results from the Phase III NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen,” said Christelle Huguet, EVP and Head of Research and Development, Ipsen. “With today’s approval, this Onivyde (NALIRIFOX) regimen can now offer a potential new standard-of-care treatment option with proven survival benefits for people living with metastatic pancreatic adenocarcinoma in the U.S.”

Pancreatic adenocarcinoma (PDAC) is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally. Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV). Characterized as a complex cancer due to rapid tumor progression, limited genetic targets and multiple resistance mechanisms, mPDAC has a poor prognosis with fewer than 20% of people surviving longer than one year. Overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S... Ipsen's Press Release -

BariaTek Medical Announces the First-in-Human Implantation of Its BariTon™ Device, a Non-Surgical Gastro-Intestinal Medical Device Aiming to Replicate the Efficacy of Obesity Surgery Without the Invasiveness

PARIS--February 06, 2024--BariaTek Medical, a privately held medical device company dedicated to the development of minimally invasive endoscopically delivered solutions to treat obesity and diabetes, founded by Truffle Capital, announced it has initiated enrollment of patients in its First-in-human clinical trial in both Australia and Uzbekistan, and has successfully performed its first-in-human implantation.

Obesity is a chronic and debilitating disease affecting more than one billion people worldwide. It bears a tremendous economic burden to healthcare systems surpassing that of cardiovascular diseases and cancer and its prevalence is increasing worldwide. It often leads to diabetes, high blood pressure, heart disease and reduced life expectancy.

Bariatric surgery currently remains the most effective approach to treat obesity and limits the resulting complications, but surgery is poorly perceived, alters anatomy permanently, is costly, and can result in severe adverse events. Obesity pharmaceutical therapies could provide an effective alternative solution for some patients, but they are very expensive and poorly tolerated in many, resulting in their cessation and corresponding regain of the lost weight. Furthermore, they could be associated with multiple under-reported side-effects and off-label prescriptions. As for available minimally invasive endoscopic solutions, they enjoy variable safety but lack efficacy.

BariaTek Medical’s product candidate, the BariTon™, is a soft, atraumatic, reversible implant that is delivered via a simple endoscopy through the mouth within a few minutes and in an outpatient setting. It consists of a gastric part and an intestinal part, thereby having a dual effect: reduced food intake and calorie absorption. The BariTon™ is expected to be the first implant of its kind to potentially mimic the efficacy of sleeve gastrectomy and bypass surgery1 and offer superior safety, ease of use, reversibility, and lower cost... BariaTek Medical’s Press Relase -