FDA
Jefferies analysts envision a steady launch curve that could ultimately drive meaningful sales from people who are dissatisfied with existing treatments.
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Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
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The FDA said it found an issue with the “size of the treatment effect and clinical relevance” of Ardelyx’s new drug tenapanor without providing additional details.
On Friday, the agency approved belumosudil as a new treatment option for anyone over 12 with cGVHD after two prior lines of therapy have failed.
The CDC Advisory Committee on Immunization Practices is planning a meeting in October to recommend the vaccine’s use in adults.
The FDA has historically tended to keep more contentious relationships with some companies private. But recently, the agency appears to be publicly scolding some biopharma companies.
It was based on data from the APOLLO trial showing the drug significantly decreased the risk of progression or death by 37% compared to dexamethasone alone.
The company said that it values the FDA’s feedback and is happy that the agency has accepted its request to provide insights on its Hepatitis B development program.
The first nonsteroidal mineralocorticoid receptor antagonist (MRA) is approved for adults with chronic kidney disease associated with type 2 diabetes.
While the drug showed significant improvement in patients on a 200mg daily dose of filgotinib, it may not be promoted in the states any time soon.
Acting commissioner of the U.S. FDA asked the independent Office of the Inspector General to investigate how the FDA and representatives of Biogen interacted prior to the FDA’s approval of the company’s Aduhelm (aducanumab) for Alzheimer’s disease.
The expanded approval was made based on positive data from a second interim analysis of the Phase II KEYNOTE-629 trial.