American green light for Teva
Teva just announced that the FDA has approved a new formulation of its austedo (deutetrabenazine). This medicine is now authorized in the form of prolonged-release tablets, with a once-daily intake; it is indicated in adults for tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). Austedo is a flagship drug from the Israeli laboratory. In 2022, it sold for $971 million.
Positive CHMP opinion for AbbVie
The Renew (upadacitinib) d’AbbVie has received a positive CHMP opinion from the EMA for the treatment of adults with moderate to severe Crohn’s disease. This pathology is a chronic systemic disease, which is manifested by inflammation of the gastrointestinal tract, causing persistent diarrhea and abdominal pain. In Europe, Rinvoq is already approved once morest six other inflammatory diseases.
VOS INDICES
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Priority review for Valneva
The US health agency has granted priority review status (priority review) the chikungunya vaccine candidate from Nantes biotech Valneva, VLA1553. In addition, the FDA has set a target date for completing the review of the application for approval at the end of August 2023. Valneva communicated the latest final data from the phase III trial of the compound in December 2022. VLA1553 is a monovalent live attenuated vaccine candidate.
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