Aimmune Therapeutics presented new data on its AR101 peanut allergy therapy as well as a real-world data study at the American College of Asthma, Allergy and Immunology (ACAAI) Annual Scientific Meeting in Houston.
Ahead of the keenly anticipated independent panel set to discuss Aimmune’s peanut allergy immunotherapy on Friday, FDA staff issued a predictable review on Wednesday, highlighting the potential safety and tolerability issues associated with the product, while backing its efficacy.
While peanut allergy therapies from Aimmune and DBV Technologies are locked in a race to the finish line, influential cost-effectiveness watchdog ICER has determined that neither therapy offers superior net health benefit compared to strict peanut avoidance, in a final report published on Wednesday.
Aimmune Therapeutics said Thursday the Food and Drug Administration's advisory committee on allergenic products will review its experimental peanut allergy pill in September, setting a date for an initial test of the growing allergy desensitization field.
Get ready for some blockbuster drug launches that could get intense.
Clarivate Analytics has offered a report on experimental drugs entering the market soon that are expected to generate sales above $1 billion in 2023. Every potential blockbuster is important to the company that launches it, but there are a few in the annual Clarivate report that are more important than usual. In 2019, AbbVie (NYSE: ABBV), Alexion Pharmaceuticals (NASDAQ: ALXN), and Aimmune Therapeutics (NASDAQ: AIMT) face upcoming drug launches that they can't afford to fumble.
Aimmune Therapeutics expects to know by the end of March whether the Food and Drug Administration will proceed with review of its peanut allergy treatment, the company said Thursday, clearing up some lingering confusion regarding the drug's regulatory status.
Aimmune Therapeutics has confirmed that the government shutdown will delay the FDA’s review of AR101, its oral immunotherapy for peanut allergy.
Aimmune Therapeutics $AIMT has detailed the results of its Phase III study of its peanut allergy therapy known as AR101 in the New England Journal of Medicine in an article — and independent assessment — that will likely stoke its supporters as much as the skeptics in the field.