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ALS drug gets rare second review at high-stakes FDA meeting

A closely watched experimental drug called AMX0035 for Amyotrophic Lateral Sclerosis (ALS) got an unusual second look from U.S. regulators on September 7, following intense pressure to approve the treatment for those with the fatal illness.

Also known as Lou Gehrig’s disease, the sickness destroys nerve cells needed for basic functions like walking, talking and swallowing. Patients and their families have rallied behind the drug from Amylyx Pharma, launching an aggressive lobbying campaign and enlisting members of Congress to push the Food and Drug Administration (FDA) to grant approval.

In a rare move, the FDA convened a second meeting of neurology advisers who narrowly voted against the company’s drug in March. The panel was reviewing new statistical analyses from Amylyx and planned to vote again on whether to recommend approval. An internal review by FDA scientists posted ahead of the meeting struck a negative tone, concluding that the company’s updated analysis was not “persuasive” and provided “no new data.” On the other hand, the FDA’s instructions to the panel stressed the need for regulatory flexibility when considering drugs for deadly diseases. A final FDA decision is expected later this month.

(Excerpt taken from: https://news.yahoo.com/als-drug-gets-rare-second-173358284.html)

 

Glossary:
High-stakes: importante
Illness: doença
Rally behind: apoiar publicamente
Launch: lançar
Stress: frisar

Patients and their families have

READ THE TEXT BELOW, THEN ANSWER THE FOLLOWING QUESTIONS.

ALS drug gets rare second review at high-stakes FDA meeting

A closely watched experimental drug called AMX0035 for Amyotrophic Lateral Sclerosis (ALS) got an unusual second look from U.S. regulators on September 7, following intense pressure to approve the treatment for those with the fatal illness.

Also known as Lou Gehrig’s disease, the sickness destroys nerve cells needed for basic functions like walking, talking and swallowing. Patients and their families have rallied behind the drug from Amylyx Pharma, launching an aggressive lobbying campaign and enlisting members of Congress to push the Food and Drug Administration (FDA) to grant approval.

In a rare move, the FDA convened a second meeting of neurology advisers who narrowly voted against the company’s drug in March. The panel was reviewing new statistical analyses from Amylyx and planned to vote again on whether to recommend approval. An internal review by FDA scientists posted ahead of the meeting struck a negative tone, concluding that the company’s updated analysis was not “persuasive” and provided “no new data.” On the other hand, the FDA’s instructions to the panel stressed the need for regulatory flexibility when considering drugs for deadly diseases. A final FDA decision is expected later this month.

(Excerpt taken from: https://news.yahoo.com/als-drug-gets-rare-second-173358284.html)

 

Glossary:
High-stakes: importante
Illness: doença
Rally behind: apoiar publicamente
Launch: lançar
Stress: frisar

Lou Gehrig’s disease is

Read the following text to answer question.

 

Studies have shown that even minimal physical activity immediately enhances activity and connectivity in the hippocampus, and connectivity in other cortical areas associated with learning and memory

And these effects are not, as previously thought, a result of the body entering a stress response and releasing cortisol. Keep up the activity and, after 12 weeks, improvements in cerebral blood flow are evident.

And you most definitely don’t need a gym. Simply walking has huge benefits – outdoors, in nature, preferably.

Head out onto that unpaved trail and you’ll encounter uneven ground, a tangle of roots and rocks that demands attention to avoid tripping. You’ll be bombarded by new stimuli and inputs.

Every minute of walking requires hundreds of micro-decisions about where to place your foot, how much pressure to use when setting your foot down and picking it up again, how to balance yourself, how to lift off your foot to move forward to the next step. You have to be attentive to avoid getting whacked in the face by low-hanging branches, to brush away spiders, flies, and midges, or swerve to avoid the occasional runner, dog or child.

The number of variables – things that could happen to you – is infinite. The terrain, the people, the vegetation, even the weather – it’s all changing.

This is the kind of navigation our brains evolved to perform. This is the kind of embodied cognition that strengthens synapses and rejuvenates hippocampal memory systems, motor-action planning systems, and eye-body coordination.

Outdoors, anything can happen. And that’s the most potent way of keeping the brain flexible and active that we have so far discovered.

Available at: https://www.sciencefocus.com/the-human-body/ exercise-and-the-brain-why-moving-your-body-matters/. Accessed on: Feb. 16, 2023.

The text argues that

Available at: https://www.npr.org/2017/04/14/523992723/ outgoing-new-yorker-cartoon-editorsays-being-funny-is-being-awake Access: Aug 22, 2022.

 

The cartoon can be interpreted as a criticism towards

Long COVID – illness that persists for weeks or months after infection with SARS-CoV-2 – has proved difficult to study, not least because the array of symptoms makes it hard to define. Even finding out how common it is has been challenging. Some studies have suggested that it occurs in as many as 30% of people infected with the virus. But a November study of about 4.5 million people treated at US Department of Veterans Affairs (VA) hospitals suggests that the number is 7% overall and lower than that for those who were not hospitalized.

Available at: https://www.nature.com/articles/d41586-022- 01453-0 Access: Aug 22, 2022.

 

The paragraph above was extracted from an article titled “Long COVID risk falls only slightly after vaccination, huge study shows,” which discusses the difficulties associated with studying long COVID.

 

It is possible to say that the function of the comparison between the studies reported is to

    Chat GPT may make things up, but it does so fluently in more than 50 languages. It is not only able to generate remarkably realistic English, but it is also able to instantly blurt out text in more than 50 languages – the precise number is apparently unknown to the system itself.

    Asked (in Spanish) how many languages it can speak, ChatGPT replies, vaguely, “more than 50”, explaining that its ability to produce text will depend on how much training data is available for any given language. Then, asked a question in an unannounced switch to Portuguese, it offers up a sketch of your columnist’s biography in that language. Most of it was correct, but it had him studying the wrong subject at the wrong university. The language itself was impeccable, and Portuguese is one of the world’s biggest languages.

Disponível em: www.economist.com. Acesso em: 5 jun. 2023 (adaptado).

 

Even by the standards of tech innovations, ChatGPT’s public launch last year was extreme. However, the article from the Economist says that the artificial intelligence