Approvals
The FDA and Regeneron are reportedly in talks to set up an advisory committee meeting to discuss the BLA ahead of the target action date.
The news of a unanimous decision by the adcom came just two days after the agency issued a 45-page document that contained vague comments on the drug.
The FDA gave Ardelyx a CRL on the NDA but did not mention anything about clinical pharmacology or biopharmaceutics, safety, or any related non-clinical concerns.
Today’s approval was based on the Phase III KEYNOTE-826 trial that evaluated Keytruda and chemotherapy with or without bevacizumab compared to the same chemotherapy treatment.
The FDA said that there had been concerns over the reduced effectiveness of the Moderna COVID-19 vaccine against symptomatic disease.
The incidence of congenital athymia is about 17 to 24 lives births each year in the U.S. The therapy is a one-time regenerative tissue-based therapy.
Roche’s candidate drug for Alzheimer’s treatment received breakthrough therapy designation which has increased its chance of getting full FDA approval.
If authorized, it could be available in the U.S. before the end of the year. It is also working to submit applications to other regulators worldwide.
The FDA approved ChemoCentryx’s Tavneos (avacopan) as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).
Based on results from the Phase II and Phase III TAK-620-303 (SOLSTICE) trials, members of the AMDAC unanimously voted in favor of using maribavir.
PRESS RELEASES