There’s new hope for ALS patients after the FDA eased its stance on early approval for a promising new treatment. In early clinical trials, the treatment slowed the progression of symptoms from this devastating neurodegenerative disease. From WBUR:
The Food & Drug Administration campus in Silver Spring, Md. This photo was taken Oct. 14, 2015.
The Food and Drug Administration has opened the door to early approval for a new ALS drug treatment despite limited, though promising, evidence of its effectiveness. After completing two clinical trials for its drug AMX0035, the Cambridge-based company Amylyx reported earlier this year that the FDA wanted to see results from another round of clinical trials before the company could submit a new drug application, which is a proposal for a drug to be sold in the U.S.of trials before allowing a company to submit an application.
The company plans to submit the application in the coming months and will still conduct the final phase of clinical trials. While awaiting the FDA reviewKlee said Amylyx may also create an expanded access program for those who wish to take the drug but do not meet the criteria for the trials. “[For] people with ALS, every single day matters. We need to do all of these things to promote access as quickly and efficiently as we can,” Klee said.. It’s a devastating disease that causes the nerve cells involved with muscle function to stop working and die.
Canada Latest News, Canada Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
FDA advisory group votes against Covid vaccine booster doseBREAKING: FDA advisory panel votes against offering Covid-19 vaccine booster shots for the general population, citing concerns about the safety of the boosters in younger people.
Read more »
FDA advisers vote to oppose Pfizer/BioNTech COVID-19 vaccine boosterA panel of outside advisers to the U.S. Food and Drug Administration on Friday voted against approval of a booster dose of the Pfizer Inc /BioNTech SE COVID-19 vaccine for people aged 16 and older.
Read more »
What to expect as FDA advisory panel debates Pfizer COVID booster shotsThe FDA's independent advisory committee is convening to review data submitted by Pfizer and discuss whether a booster dose is safe enough for widespread use and whether it's necessary and effective at improving protection levels against COVID-19.
Read more »
FDA panel is first key test for Biden COVID-19 booster planGovernment advisers are debating whether to recommend extra doses of the Pfizer vaccine, a key step toward the Biden administration's plan to dispense COVID-19 booster shots. Scientists have been divided over the need for boosters and who should get them.
Read more »
FDA advisory group rejects COVID-19 boosters for most, limits to high-risk groupsThe vote in favor of boosters came after the committee overwhelmingly rejected recommending the extra shots for the general population.
Read more »