Posts tagged with "Eli Lilly"

The FDA says Ozempic might block your intestines

October 12, 2023

Ozempic, the über-popular injectable diabetes drug, has had to update its potential side-effect warnings to include intestinal blockage, reports Futurism.

As CBS News first disclosed, the Ozempic label change reflects updates posted last week by the Food and Drug Administration—which acknowledged that some users experienced a condition known as “ileus,” which involves a blocking of the intestines.

The FDA stopped short, however, of saying that semaglutide, the active ingredient in Ozempic—as well as Wegovy, its counterpart prescribed for weight loss—was the cause of the condition.

“Because these reactions are reported voluntarily from a population of uncertain size,” the FDA pointed out in its update published last week, “it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.”

Of the two semaglutide injections and Mounjaro, which affects the body in a similar way but uses the drug tirzepatide as its active ingredient, Ozempic is the last to reflect on its label that ileus has occurred in some of the drug’s users, CBS notes.

This latest label update follows an early August lawsuit from a Louisiana woman, who claims that the drugmakers behind the popular diabetes shots didn’t do enough to warn consumers about its “severe” gastrointestinal side effects.

In the suit, the woman alleges that Ozempic and Moujnaro both caused her to vomit so much that she lost teeth.”As a result of using… Ozempic and Mounjaro,” the suit reads, “Plaintiff was caused to suffer from severe gastrointestinal events, which resulted in, for example, severe vomiting, stomach pain, gastrointestinal burning, being hospitalized for stomach issues on several occasions including visits to the emergency room, teeth falling out due to excessive vomiting, requiring additional medications to alleviate her excessive vomiting, and throwing up whole food hours after eating.”

In a statement to Fierce Pharma, a spokesperson for Ozempic and Wegovy maker Novo Nordisk said that these kinds of GI issues “are well-known side effects” of taking GLP-1 agonists, the class of drugs to which semaglutide belongs.

“For semaglutide,” the Danish company continued, “the majority of GI side effects are mild to moderate in severity and of short duration.”

Although ileus or intestinal blockages weren’t mentioned in that suit, these label updates could serve to protect Novo Nordisk and Eli Lilly, the maker of Moujnaro, from legal action—and, hopefully, will be taken into account by patients when weighing whether to take the increasingly-popular injections.

Research contact: @futurism

Eli Lilly to cut prices of insulin drugs by 70%, cap patient costs at $35

March 2, 2023

Eli Lilly—facing pressure to curb diabetes-treatment costswill cut the list prices for its most commonly prescribed insulin products by 70% and take other steps to make it easier for patients to afford the drugs, reports The Wall Street Journal.

On Wednesday, March 1, the Indianapolis-based company announced that the 70% price cuts will take effect in the fourth quarter for Humalog and Humulin, its two biggest-selling insulin products.

The company also said that on May 1 it would reduce the list price of an unbranded insulin it sells to $25 a vial from $82 a vial—the lowest level for any insulin that diabetes patients take around mealtimes, and less than Lilly’s list price for a Humalog vial in 1999. And it plans to improve a program capping patients’ out-of-pocket costs at $35 a month.

“The aggressive price cuts we’re announcing today should make a real difference for Americans with diabetes,” said Lilly Chief Executive David Ricks.

Drugmakers—including Lilly, Novo Nordisk and Sanofi—substantially raised the prices for their insulin products during the 2010s. Now, the products cost hundreds of dollars a month. Humalog currently has a list price of $530 for a five-pack of injection pens and $274 for a vial; although Lilly said most people with commercial insurance and Medicare pay no more than $95 a month.

The manufacturers have said that, while list prices increased, they have had to pay larger rebates to companies that manage drug benefits.

Yet, because of the high prices, people without insurance or with high-deductible health plans can have trouble affording the products—forcing them to ration use.

To ease the burden, some U.S. states have enacted insulin-cost caps in recent years. Last year’s Inflation Reduction Act mandated that patients covered by the federal Medicare health-insurance program should pay no more than $35 a month in copays or other out-of-pocket costs for an insulin prescription.

In his State of the Union address in February, President Joe Biden called for that $35 monthly cap to be expanded beyond Medicare to include every diabetes patient.

In addition to reducing the list prices for its top-selling insulins, Lilly said it would introduce on April 1 a new insulin, named Rezvoglar, that is a copycat version of Sanofi’s Lantus insulin. Lilly will list its price at $92 for a five-pack of injection pens, a 78% discount to the list price for Lantus.

The company said it would make improvements to its program, introduced in 2020, to cap insulin out-of-pocket costs at $35 a month. Participating pharmacies will now implement that cap automatically when people with commercial insurance fill their prescriptions, rather than requiring people to present a Lilly savings card.

People without insurance can continue to cap monthly costs at $35 for Lilly insulin products by using a savings card that can be downloaded immediately online, the company said.

Research contact: @WSJ

GlaxoSmithKline requests emergency authorization from FDA for COVID monoclonal antibody drug

March 29, 2021

On Friday, March 26, GlaxoSmithKline and Vir Biotechnology  applied for an emergency use authorization from the Food and Drug Administration for their monoclonal antibody drug, CNBC reports.

The companies are requesting clearance for use by high-risk patients, age 12 and older.

The FDA submission is based on an interim analysis of a phase three trial that evaluated the drug for the early treatment of COVID-19 in adults at high risk of hospitalization. The drug reduced hospitalizations or death from COVID by 85% compared with a placebo. The trial results were based on 583 patients.

“As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrolment due to evidence of profound efficacy,” the companies said in a statement.

The companies started testing the antibody on early-stage COVID patients in August, CNBC notes—hoping to keep symptoms from progressing. Antibody drugs gained attention after they were used to treat former President Donald Trump last year.

U.S. health officials say antibody drugs already authorized for use—from Regeneron and Eli Lilly—are being underutilized.

GSK said the companies will also continue discussions with the European Medicines Agency and other global regulators to make the drug available to COVID patients as soon as possible.

Research contact: @CNBC

Lilly to offer insulin at 50% lower price in U.S. pharmacies

March 5, 2019

About 1.25 million Americans suffer from Type 1 diabetes—a serious condition in which the body fails to properly regulate blood sugar—and for them, buying insulin is a “do or die” decision.

Thus, when the price of prescription insulin at U.S. pharmacies began to rise rapidly within the past few years—more than tripling from $300 for a 90-day prescription to $1,000 or more today—they and their families began having to choose between other necessities and the price of the life-saving hormone.

N o generic version of the drug existed, and three manufacturers—Eli Lilly (Indianapolis), Sanofi (Paris), and Novo Nordisk (Bagsværd, Denmark)—control 99% of the market

Now, Eli Lilly has announced that it will step up to help patients nationwide-offering a 50% lower-priced generic version of Humalog (insulin lispro injection 100 units/mL) at pharmacies in the United States.

“We’ve engaged in discussions about the price of insulin with many different stakeholders in America’s health care system: people living with diabetes, caregivers, advocacy groups, health care professionals, payers, wholesalers, lawmakers, and leading health care scholars,” said Lilly’s CEO David A. Ricksin a company release, adding, “Solutions that lower the cost of insulin at the pharmacy have been introduced in recent months, but more people need help. We’re eager to bring forward a low-priced rapid-acting insulin.

“The significant rebates we pay on insulins do not directly benefit all patients. This needs to change,” Ricks said. “There are numerous ideas, including the rebate reform proposal from HHS. For people with diabetes, a lower-priced insulin can serve as a bridge that addresses gaps in the system until a more sustainable model is achieved.”

The lower-priced version will be called Insulin Lispro—the same molecule as Humalog—and will be available in vial and pen options. The list price of a single vial will be $137.35. The list price of a five-pack of KwikPens will be $265.20.

Vials and pens of the lower-priced insulin have been manufactured, and Lilly will now work with supply chain partners to make them available in pharmacies as quickly as possible. It will be made available as an authorized generic through a Lilly subsidiary, ImClone Systems.

Humalog also will remain available for people who want to continue accessing it through their current insurance plans. Introducing an alternative insulin option allows Lilly to provide a lower-priced insulin more quickly while providing payers time to renegotiate downstream contracts and adjust to new system economics.

“While this change is a step in the right direction, all of us in the health care community must do more to fix the problem of high out-of-pocket costs for Americans living with chronic conditions,” Ricks said. “We hope our announcement is a catalyst for positive change across the U.S. healthcare system.”

Lilly’s Insulin Lispro is one of many initiatives the company has introduced to deliver lower out-of-pocket options to people living with diabetes. After exploring the logistics and feasibility of an authorized generic, Lilly began preparing manufacturing, labeling, and shipping plans last year for the possibility of Lilly’s Insulin Lispro. People should call the Lilly Diabetes Solution Center at (833) 808-1234 to learn whether Lilly’s Insulin Lispro, or another option, is the best financial choice for them.

Humalog and Insulin Lispro are available by prescription only.

Research contact: @LillyPad