Crime Demand for weight-loss drugs fuels global rise in counterfeits

[LeonardoBjj]

PHARMACEUTICALS
Weight-loss drug Wegovy could get expanded FDA approval within six months, Novo Nordisk says

Karen Gilchrist@_KARENGILCHRIST

• Novo Nordisk said Thursday that its blockbuster weight-loss drug Wegovy could receive expanded approval from the U.S. Food and Drug Administration within six months.
• Chief Financial Officer Karsten Munk Knudsen said the company had received priority review in its application for approval of Wegovy as a treatment for reducing the risk of cardiovascular disease.
• A greenlight from the health agency could potentially boost the insurance coverage prospects of the highly sought-after drug.

Novo Nordisk said Thursday that its blockbuster weight-loss drug Wegovy could receive expanded approval from the U.S. Food and Drug Administration within six months.

Chief Financial Officer Karsten Munk Knudsen told CNBC that the Danish pharmaceutical company had received priority review in its application for approval of Wegovy as a treatment for reducing the risk of cardiovascular disease.

Earlier Thursday, Novo Nordisk in its third-quarter earnings announced plans to get expanded approval from the FDA, but shared no timeline. It also reported record profits and sales for the period on the back of the runaway success of its obesity drug.

[paste:font size="5"]reduced the risk of major cardiovascular events such as heart attacks or strokes by 20%, compared with a placebo.

“The SELECT study is, in an obese population with established cardiovascular disease, does Wegovy reduce cardiovascular risk? And the answer is, yes it does, by 20%,” Knudsen said Thursday.

The results of the closely watched “SELECT” trial were seen as a boon for Novo Nordisk’s ambitions of moving beyond Wegovy’s image as a “vanity drug.”

The findings provided an added boost for the company’s stock, which has been on the up this year. Shares were 1.5% higher Thursday morning following its earning’s report; over the year to date, shares are almost 45% higher.

A greenlight from the health agency could potentially boost the insurance coverage prospects of the highly sought-after drug.

“I would say from today, [the outcome will be] less than six months,” Knudsen told CNBC’s Julianna Tatelbaum on “Street Signs.”

Knudsen said the company will present a detailed copy of the trial findings in approximately 10 days, after which the FDA will have six months to provide its verdict.

He added that approval would expand the use cases of the drug, bolstering the chances of insurance companies paying for the treatment. Some insurers have so far been reluctant to cover the drug — which has a U.S. list price of $1,350 a month — solely for weight-loss purposes.

“The pricing of the products are also a reflection of the value that they give to society,” Knudsen said.

“So the more data we are able to generate, whether it’s on cardiovascular disease or chronic kidney disease or other comorbidities, that is of course part of the overall value story when we discuss with payers and insurers.”

However, even with approval, supply shortages could continue to hamper rollout of the drug. Knudsen said Thursday that the company is continuing to ramp up production.

“I can promise you coming into next year that we’re significantly scaling Wegovy supply,” he said.

https://www.cnbc.com/2023/11/02/nov...could-get-new-fda-approval-in-six-months.html

 

[LeonardoBjj]

US FDA approves Lilly weight-loss drug, will compete with Novo's Wegovy
By Patrick Wingrove and Leroy Leo

Nov 8 (Reuters) - The U.S. Food and Drug Administration on Wednesday approved Eli Lilly's (LLY.N) drug for weight loss, giving the U.S. drugmaker official entry into a lucrative market that has captured Wall Street's enthusiasm this year.

The FDA approved tirzepatide for weight loss under the brand name Zepbound. It has been available as Mounjaro for type 2 diabetes since 2022 and had been increasingly used "off-label" for weight loss while the obesity approval was pending.

Zepbound will be available in the U.S. by the end of the year at a list price of $1,059.87, according to Lilly. That compares with a list of $1,349 per-package for Novo Nordisk's (NOVOb.CO) wildly popular weight-loss drug Wegovy.

The Lilly drug was approved for use by adults with a body mass index (BMI) - a measure of weight based on height - of at least 30, or a BMI of 27 or more if a patient also has another weight-related health issue, such as heart disease.

"Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” John Sharretts, a director in the FDA’s Center for Drug Evaluation and Research, said in a statement.

The Indianapolis-based drugmaker said it is launching a commercial savings card program to make Zepbound cost as little as $25 for patients whose insurance agrees to cover the drug, and $550 for those whose insurance does not.

Eli Lilly shares have soared 67% in 2023 based on anticipation of approval of the drug for weight loss, making it the most valuable healthcare company on the S&P 500 index (.SPX). Even though the approval was widely expected, Lilly shares were up 1.8% in afternoon trade.

Mounjaro had sales of $1.41 billion in the third quarter with Lilly acknowledging supply constraints. After Wednesday's FDA approval, Lilly can now promote the drug for weight loss.

The enormous demand for new weight-loss treatments could support as many as 10 competing products with annual sales reaching up to $100 billion within a decade, mostly in the United States, industry executives and analysts said earlier this year.

The approval was based partly on data from a late-stage trial of 2,539 adults with obesity, or excess weight and weight-related medical problems not including diabetes, as an adjunct to diet and exercise.

Zepbound's most common side effects include nausea, diarrhea, hair loss and gastroesophageal reflux disease, according to Lilly.

Reporting by Leroy Leo and Bhanvi Satija in Bengaluru; Editing by Shinjini Ganguli and Bill Berkrot

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-lillys-weight-loss-drug-2023-11-08/