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Much-debated drug from Amylyx for Lou Gehrig’s disease wins FDA approval

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Much-debated drug from Amylyx for Lou Gehrig’s disease wins FDA approval

A much-debated drug for Lou Gehrig’s illness received U.S. approval on Thursday from the Meals and Drug Administration.

The nod represents a long-desired victory for sufferers, although it’s prone to renew questions concerning the scientific rigor behind authorities opinions of experimental medicines, because the Related Press has reported. 

The FDA authorised the drug from Amylyx Prescription drugs primarily based on outcomes from one small, mid-stage research, the AP reported.

FDA PANEL VOTES TO RECOMMEND AMYLYX ALS DRUG

Within the small medical research, sufferers with the debilitating illness appeared to progress extra slowly and survive a number of months longer. 

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Take a look at tubes are seen in entrance of Amylyx emblem on this illustration, July 24, 2022. 
(REUTERS/Dado Ruvic/Illustration)

“This approval supplies one other vital therapy possibility for ALS, a life-threatening illness that at present has no treatment,” Dr. Billy Dunn, FDA’s neurology drug director, mentioned in an announcement.

Usually, the FDA requires two giant research or one research with “very persuasive” survival outcomes for approval.

Third authorised treatment for ALS

The newly authorised drug is named Relyvrio.

It is the third U.S.-approved drugs for the therapy of amyotrophic lateral sclerosis, or ALS — which destroys nerve cells wanted for fundamental features resembling strolling, speaking and swallowing.

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“I believe it demonstrates the FDA’s capacity to be facile and I believe it demonstrates numerous tenacity on the a part of ALS sufferers and advocates,” mentioned Dr. Catherine Lomen-Hoerth, an ALS specialist on the College of California San Francisco, the AP reported.

“The corporate actually tried to do all the pieces doable to get this probably promising drug out to sufferers,” she added. 

Amylyx’s drug is the newest in a sequence of neurological medication which have received FDA approval regardless of questionable effectiveness knowledge, based on the AP. 

The company continues to be going through two authorities probes into its approval of the Alzheimer’s drug Aduhelm final 12 months, which has not but been proven to gradual the illness, the AP famous.

In early Sept., FDA advisers — reversing a earlier choice — voted to advocate approval of the drug. 

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However in a web based memo summarizing its choice, the FDA mentioned “regulatory flexibility” was applicable for approving Relyvrio, “given the intense and life-threatening nature of ALS and the substantial unmet want.”

In early Sept., FDA advisers — reversing a earlier choice — voted to advocate approval of the drug. 

The Peripheral and Central Nervous System Medicine Advisory Committee vote was 7-2 in favor of approval after hours of debate relating to the power and reliability of the corporate’s analyses.

This 2018 photo provided by Amylyx shows the company's co-founders Joshua Cohen, left, and Justin Klee in Cambridge, Mass. 

This 2018 photograph offered by Amylyx exhibits the corporate’s co-founders Joshua Cohen, left, and Justin Klee in Cambridge, Mass. 
(Amylyx through AP)

In March, the panel declined to advocate FDA approval for the treatment, as a result of what the group mentioned was an absence of “considerably persuasive” knowledge.

Lately, nonetheless, the FDA confronted quite a lot of strain from ALS sufferers, advocates and members of Congress, the AP famous. 

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The company obtained over 1,300 written feedback from the ALS neighborhood in assist of the therapy.

The corporate didn’t instantly disclose the worth on Thursday, however mentioned it deliberate to announce the knowledge on a name with traders on Friday morning.

FDA approval is anticipated to compel insurers to cowl Amylyx’s treatment.

Amylyx, primarily based in Cambridge, Mass., didn’t instantly disclose the worth on Thursday, however the firm mentioned it deliberate to announce the knowledge on a name with traders on Friday morning, the AP reported. 

In Canada, the place the drug obtained approval in June, the corporate has proposed a value equating to $165,000.

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AMX0035, because the drug can also be recognized, is reportedly a mix of two current merchandise. One is a dietary complement known as taurursodiol, which could be bought on-line. The opposite is a prescription drug known as sodium phenylbutyrate, used to deal with a uncommon sort of metabolic dysfunction.

The mixture is supposed to decelerate ALS.

ALS is a progressive neurodegenerative illness that impacts nerve cells and the spinal wire. There are two sorts of ALS — sporadic, which is the commonest kind within the U.S.; and familial — which suggests it’s inherited, based on ALS.org. Scientists have but to find out the precise explanation for the illness. 

Julia Musto of Fox Information Digital, in addition to the Related Press and Reuters, contributed to this report.

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fatty15 has the essential nutrient to ease stress and well-being

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fatty15 has the essential nutrient to ease stress and well-being



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Summer is tick season, but these tips can help you avoid the bloodsucking bugs

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Summer is tick season, but these tips can help you avoid the bloodsucking bugs

Tick season is starting across the U.S., and experts are warning the bloodsuckers may be as plentiful as ever.

Another mild winter and other favorable factors likely means the 2024 tick population will be equal to last year or larger, some researchers say.

“It’s very bad and has only been getting worse,” said Susanna Visser of the Centers for Disease Control and Prevention.

TICK BITES AND LYME DISEASE: WHAT TO DO IF A TICK BITES YOU OR YOUR PET

An increasing variety of ticks are pushing into new geographical areas, bringing unusual diseases. Exotic southern species like the Gulf Coast tick and the lone star tick are being detected in New York and other northern states, for example.

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But the tick that experts warn of the most is a common blacklegged tick, which is found mainly in forests and spreads Lyme disease. Infection rates begin to peak in May, and U.S. health officials estimate nearly half a million Lyme disease infections happen annually.

Here’s a look at what’s expected this year and how you can protect yourself.

An adult deer tick, also known as the blacklegged tick, crawls on a fingernail at Connetquot State Park in Oakdale, New York on Dec. 27, 2011. (Bill Davis/Newsday RM via Getty Images)

TICK FACTS

Ticks are small, eight-legged bloodsucking parasites — arachnids, not insects — that feed on animals and sometimes people. Some ticks are infected with germs that can cause illness, and they spread those germs when they bite.

There is no widely accepted estimate of how many ticks there are from one year to the next, but there is a scientific consensus that they are an increasingly common health hazard in large portions of the United States.

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Blacklegged ticks — also known as deer ticks, since they feed on deer — are among the most common ticks in the eastern half of the U.S. They were plentiful centuries ago, then diminished when forests were cut down and deer were hunted, and rebounded alongside deer and wooded suburbs. The ticks have spread out from pockets in New England and the Midwest over a wider range.

Tick populations cycle throughout the year and their numbers depend on a few factors. They like warm, humid weather, and more can be seen after a mild winter. The more deer and mice available to feed matters, too.

Overall, the blacklegged tick population has been expanding for at least four decades, researchers say.

“This is an epidemic in slow motion,” said Rebecca Eisen, a CDC research biologist and tick expert.

2024 TICK SEASON FORECAST

Weather can play a role in the severity of a tick season.

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Very cold, dry winters can whittle down tick populations, but recent winters have been mild — a trend some attribute to climate change.

As Scott Williams, a tick researcher at the Connecticut Agricultural Experiment Station, said: “Winters are no longer limiting the tick population.”

Ticks can withstand the heat but tend to almost hibernate when it’s a dry summer. That happened in Maine in 2020 through 2022, said Chuck Lubelczyk, a vector ecologist at the MaineHealth Institute for Research.

But last year was a very wet year, and tick activity multiplied in Maine — the state with the highest incidence of Lyme disease in the country. Weather service predictions call for higher temperatures and precipitation, so “on paper, at least, it could be a very good year for the ticks,” Lubelczyk said.

In Wisconsin, adult ticks were out longer than usual due to a mild winter. The tick nymphs are starting to emerge, and a wet spring is setting the stage for the possibility that the population will be robust, said Xia Lee, an entomologist at the Wisconsin Department of Health Services.

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Ditto New York.

“It will be as bad as last year, or worse,” said Saravanan Thangamani, who studies ticks and tickborne diseases at SUNY Upstate Medical University in Syracuse.

WHAT IS LYME DISEASE?

Not all ticks are infected with disease-causing germs — about 20% to 30% of the blacklegged tick nymphs that emerge in the Northeast and Midwest this spring and into summer will be carrying the bacteria that causes Lyme disease, experts estimate.

Lyme disease symptoms tend to start between three and 30 days after a bite occurs and can include fever, headache, fatigue and a bull’s-eye-like rash. If you get bitten and develop symptoms, see a doctor to get treated with antibiotics.

HOW TO KEEP TICKS OFF OF YOU

Experts say the best thing to do is take steps to avoid a tick bite in the first place.

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If you go outdoors, make note of wooded areas and where grassy properties start bleeding into wooded areas. Ticks tend to perch on ankle-level vegetation with their upper legs outstretched, waiting to latch on to an unsuspecting dog or human.

Try to walk in the middle of paths, wear light-colored and permethrin-treated clothing and use Environmental Protection Agency (EPA)-registered insect repellents.

HOW TO CHECK FOR TICKS

When you come inside, check for ticks. They can be found anywhere on the human body, but common spots include around the waist, behind the knees, between fingers and toes, on underarms, in the belly button and around the neck or hairline.

They are harder to see when they are young, so look carefully and immediately pull them off with tweezers.

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The CDC does not recommend sending individual ticks to testing services for analysis, because a person might get more than one tick bite and the results from the tested tick may not be sufficient information.

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Pizza for Weight Loss? Top MD Says This Dough Makes It Possible

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Pizza for Weight Loss? Top MD Says This Dough Makes It Possible



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