The medicine in the diabetes drug Mounjaro helped people with obesity or who are overweight lose at least a quarter of their body weight, or about 60 pounds on average, when combined with intensive diet and exercise, a new study shows.

By comparison, a group of people who also dieted and exercised, but then received dummy shots, lost weight initially but then regained some, researchers reported Sunday in the journal Nature Medicine.

“This study says that if you lose weight before you start the drug, you can then add a lot more weight loss after,” said Dr. Thomas Wadden, a University of Pennsylvania obesity researcher and psychology professor who led the study.

The results, which were also presented Sunday at a medical conference, confirm that the drug made by Eli Lilly & Co. has the potential to be one of the most powerful medical treatments for obesity to date, outside experts said.

“Any way you slice it, it’s a quarter of your total body weight,” said Dr. Caroline Apovian, who treats obesity at Brigham and Women’s Hospital and wasn’t involved in the study.

The injected drug, tirzepatide, was approved in the U.S. in May 2022 to treat diabetes. Sold as Mounjaro, it has been used “off-label” to treat obesity, joining a frenzy of demand for diabetes and weight-loss medications including Ozempic and Wegovy, made by Novo Nordisk.

All the drugs, which carry retail price tags of $900 a month or more, have been in shortage for months.

Tirzepatide targets two hormones that kick in after people eat to regulate appetite and the feeling of fullness communicated between the gut and the brain. Semaglutide, the drug used in Ozempic and Wegovy, targets one of those hormones.

The new study, which was funded by Eli Lilly, enrolled about 800 people who had obesity or were overweight with a weight-related health complication — but not diabetes. On average, study participants weighed about 241 pounds (109.5 kilograms) to start and had a body-mass index — a common measure of obesity — of about 38.

After three months of intensive diet and exercise, more than 200 participants left the trial, either because they failed to lose enough weight or for other reasons. The remaining nearly 600 people were randomized to receive tirzepatide or a placebo via weekly injections for about 16 months. Nearly 500 people completed the study.

Participants in both groups lost about 7% of their body weight, or almost 17 pounds (8 kilograms), during the diet-and-exercise phase. Those who received the drug went on to lose an additional 18.4% of initial body weight, or about 44 pounds (20 kilograms) more, on average. Those who received the dummy shots regained about 2.5% of their initial weight, or 6 pounds (2.7 kilograms).

Overall, about 88% of those taking tirzepatide lost 5% or more of their body weight during the trial, compared with almost 17% of those taking placebo. Nearly 29% of those taking the drug lost at least a quarter of their body weight, compared with just over 1% of those taking placebo.

That’s higher than the results for semaglutide and similar to the results seen with bariatric surgery, said Apovian.

“We’re doing a medical gastric bypass,” she said.

Side effects including nausea, diarrhea and constipation were reported more frequently in people taking the drug than those taking the placebo. They were mostly mild to moderate and occurred primarily as the dose of the drug was escalated, the study found. More than 10% of those taking the drug discontinued the study because of side effects, compared with about 2% of those on placebo.

Lilly is expected to publish the results soon of another study that the firm says shows similar high rates of weight loss. The U.S. Food and Drug Administration has granted the company a fast-track review of the drug to treat obesity, which Eli Lilly may sell under a different brand name. A decision is expected by the end of the year.

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WASHINGTON (AP) — Food and Drug Administration regulators on Tuesday approved a first-of-a-kind drug for a rare form of Lou Gehrig’s disease, though they are requiring further research to confirm it truly helps patients.

The FDA approved Biogen’s injectable drug for patients with a rare genetic mutation that’s estimated to affect less than 500 people in the U.S. It’s the first drug for an inherited form of ALS, or amyotrophic lateral sclerosis, a deadly disease that destroys nerve cells needed for basic functions like walking, talking and swallowing.

Approval came via FDA’s accelerated pathway, which allows drugs to launch based on promising early results, before they’re confirmed to benefit patients. That shortcut has come under increasing scrutiny from government watchdogs and congressional investigators.

The FDA is requiring Biogen to continue studying the drug in a trial of people who carry the genetic mutation but do not yet have ALS symptoms.

ALS patients hope the decision could lay the groundwork for more expedited approvals to fight the disease, which affects 16,000 to 32,000 people in the U.S. The FDA has long used accelerated approval to speed the availability of drugs for cancer and other deadly conditions.

The drug, tofersen, is designed to block the genetic messengers that produce a toxic form of protein that is thought to drive the disease in about 2% of ALS patients. Cambridge, Massachusetts-based Biogen will sell it under the brand name Qalsody. Patients receive three initial spinal injections of the drug over a two-week period, followed by a monthly dose. The most common side effects linked to the drug were pain, fatigue and increased spinal fluid.

Biogen’s 100-person study failed to show that the drug significantly slowed the disease compared with a dummy treatment. Patients were tracked for more than six months using a scale that measures the decline of basic movements, including writing, walking and climbing stairs.

But those who received tofersen showed significant changes in levels of the toxic protein and a second neurological chemical that is considered a key indicator of the disease’s progression.

“The findings are reasonably likely to predict a clinical benefit in patients,” the FDA said in a statement announcing the approval.

Last month an outside panel of FDA advisers voted unanimously that those changes warranted granting conditional approval while more data is gathered to confirm the drug’s benefit. The same panel said Biogen’s current data, including the failed patient study, wasn’t strong enough to warrant full approval.

FDA regulators have the authority to pull accelerated approval from drugs that fail to live up to their expected promise, though until recently, they rarely used that power. In recent years, the FDA has stepped up efforts to force unproven drugs off the market, amid criticism that too many expensive, ineffective medications remain available for years.

At the same time, the FDA has shown increased “regulatory flexibility” in approving drugs for rare and debilitating neurological diseases, including Alzheimer’s and ALS.

In September, the FDA granted full approval to another ALS drug based on one small, mid-stage study in which patients appeared to progress more slowly and survive several months longer. Normally, the FDA requires two large studies or one study suggesting a “very persuasive” improvement in survival.

Some insurers have limited access to the new drug, Relyvrio, citing its uncertain benefit and $158,000-per-year cost.

Biogen did not announce a price for its drug Tuesday but said it will be “comparable to other recently launched ALS treatments.”

The ALS Association and other patient groups hailed the approval.

“This is the second time in less than a year our community gets to celebrate the approval of a new drug to treat ALS and we have great hope for the future,” said Calaneet Balas, the group’s president and CEO.

Since last year’s approval of Relyvrio, ALS patients and advocates have continued to press the FDA to consider more treatments for the disease. That includes an experimental stem cell treatment from tiny drugmaker Brainstorm Cell Therapeutics.

In a rare move, the FDA recently agreed to hold a public meeting on the treatment, despite previously refusing to consider the company’s application, citing failed results from its principal study.

The FDA has now approved four medications for ALS, only one of which has been shown to extend life. The disease gradually destroys nerve connections needed for basic movements and — eventually — breathing. There is no cure and most people die within three to five years of diagnosis.

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WASHINGTON (AP) — The Food and Drug Administration on Thursday ordered the immediate market withdrawal of a drug intended to prevent premature births, which has remained available for years despite data showing it doesn’t help pregnant women.

The decision follows repeated efforts by Swiss drugmaker Covis Pharma to keep Makena on the U.S. market while it conducted additional studies. The medication was the only drug approved in the U.S. to help reduce the risk of early births in women with a history of preterm deliveries.

In recent months, Covis finally bowed to FDA pressure, proposing a “winding down” period of several months so that women taking the drug could complete their treatment. The FDA rejected that and said Thursday that the action against Makena and several generic versions should take effect immediately.

“Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce,” the agency said in a statement.

The injectable drug is a synthetic version of the hormone progesterone, which helps the uterus sustain pregnancy. It can cause side effects, including blood clots, depression and allergic reactions. Given those risks, FDA staffers previously concluded there was no upside to keeping the drug available, given its lack of confirmed benefit.

The final decision by FDA Commissioner Robert Califf and the agency’s chief scientist marks the first time the agency formally forced the removal of a drug that it initially approved based on promising early data. In all prior cases, drugmakers voluntarily pulled medications after the FDA made clear it intended to order removal.

The FDA expedited Makena’s approval in 2011 based on a small study suggesting it reduced rates of premature birth in women who had previously had trouble bringing a pregnancy to term. But results from a 1,700-participant study completed in late 2018 showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for babies.

The FDA has been working to get the drug off the market since then, though Covis repeatedly appealed for more time to conduct further research.

In October, the company failed to convince a panel of outside FDA advisers that the drug should stay on the market for women who face higher risks of early deliveries, including Black women.

About 10% of U.S. births come too early — before 37 weeks, raising the risk of serious health problems and even death in infants.

“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes,” Califf said in a statement Thursday. Women who have a current prescription for the drug should direct any questions to their doctor, the agency said.

The FDA has faced pressure to crack down on unproven drugs cleared under its accelerated approval program, which since the early 1990s has allowed dozens of drugs to launch based on early results.

The flipside of the program means removing drugs if their initial promise isn’t confirmed by later studies. Researchers and government watchdogs have chronicled problems with FDA’s oversight, including delays in quickly removing drugs with failed or missing confirmatory studies. In the last two years the FDA has stepped up efforts to remove unproven approvals, mainly from cancer therapies.

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A federal judge threw out a lawsuit against the maker of an anti-malarial drug blamed for causing psychotic behavior and neurological damage to U.S. servicemembers, ruling that the case had no right to be filed in California.

The proposed class-action case brought last year by an Army veteran accused Roche Laboratories Inc. and Genentech Inc. of intentionally misleading the Department of Defense and the Food and Drug Administration about the dangers of mefloquine, the generic version of the drug Lariam.

Similar cases had been brought in Canada and Australia, but the lawsuit in federal court in Northern California was the first large-scale case of its kind in the U.S., attorneys said. The U.S. military, which developed the drug during the Vietnam War, was once its largest user to combat malaria.

It was given to hundreds of thousands of troops sent to Afghanistan and Somalia. Roche, which was granted the intellectual property rights and won FDA approval for Lariam in 1989, said it manufactured its last lots for U.S. distribution in 2005. Those drugs expired in 2008 — a year before the company’s 2009 merger with Genentech. The Pentagon continued to distribute generic versions of the drug, though elite Army units were ordered to stop using mefloquine in 2013 after the FDA put a black box warning on it after it was found to cause permanent brain damage in rare cases.

The warning said it caused side effects such as dizziness, loss of balance and ringing in the ears that could become permanent. It replaced it with safer drugs. John Nelson of Florida brought the suit after he said he became permanently disabled from taking the drug during his Army service from 2005 to 2015.

Nelson said he never experienced any neuropsychiatric symptoms until he began taking mefloquine just before being stationed in Afghanistan. U.S. District Court Judge Trina Thompson ruled in San Francisco on Monday that Nelson had sufficiently alleged that the manufacturer knew about dangers of the drug and did not warn the U.S. military. But the judge said it was a stretch to apply a California law that holds name brand manufacturers responsible for warnings on the generic version of their drugs.

Nelson never lived in California and Roche and Genentech were only headquartered in the state for two months while he took the drug overseas in 2009. “It would be unfair for plaintiff to be able to bring his claims in California and, by virtue of the state’s innovator liability doctrine, he would be extended greater rights than he would be granted in his own state of residence, Florida,” Thompson wrote. The judge noted that other possible venues — New Jersey, where Roche had been based, and Florida, where Nelson lives — do not have the same law in place that would extend liability the original manufacturer of a generic drug.

Roche issued a one sentence statement asserting that lawyers were “forum shopping” and said it was pleased the court found the case didn’t belong in a California court. Nelson said his symptoms went from vivid stimulating dreams that disrupted his sleep and made him anxious to having panic attacks, paranoia, insomnia and twice tried to take his own life, the lawsuit said.

He was diagnosed as depressed and later as bipolar, though medications, including antipsychotics, did not help. After attending a conference in 2020 about effects of anti-malarial drugs, Nelson suspected he may have experienced mefloquine toxicity and pursued testing that confirmed the diagnosis.

The lawsuit sought unspecified damages for negligence, failure to warn users, and fraudulent misrepresentation, among other claims. It also sought to have the companies pay for medical monitoring of those who took the drug to understand the impacts. Attorneys for Nelson did not immediately respond to a request for comment.

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