ABBVIE

BOTOX® Cosmetic receives FDA approval for temporary improvement in moderate to severe vertical bands connecting the jaw and neck (platysma bands) in adults, becoming the first and only product with four aesthetic indications.

AbbVie's Vyalev, a subcutaneous 24-hour continuous infusion of levodopa-based therapy for advanced Parkinson's, has received FDA approval after a 18-month delay. Vyalev, delivered via a pump, aims to control motor fluctuations better than oral therapies and is expected to be covered by Medicare from the second half of 2025. The drug is already available in the EU under the name Produodopa and has been endorsed for NHS use in England and Wales.

BOTOX® Cosmetic received FDA approval for treating moderate to severe platysma bands, becoming the first aesthetic neurotoxin with four indications: forehead lines, frown lines, crow's feet, and now platysma bands. It offers a nonsurgical option to improve neck and jawline appearance by reducing muscle activity. Clinical trials showed significant patient satisfaction.

AbbVie's Vyalev (foscarbidopa and foslevodopa) receives FDA approval for treating motor fluctuations in advanced Parkinson’s disease. Vyalev is the first subcutaneous 24-hour levodopa-based infusion therapy. A Phase 3 study showed significant improvements in motor fluctuations, with most adverse reactions being mild to moderate.

REGENXBIO to present ABBV-RGX-314 data for wet AMD at AAO 2024: subretinal delivery results on Oct 19, suprachoroidal delivery for DR on Oct 21, and long-term follow-up for nAMD on Oct 21.

FDA approves AbbVie's Vyalev, a subcutaneous drug for advanced Parkinson's disease, after two prior rejections. Vyalev is the first 24-hour continuous levodopa-based therapy, already launched in 34 countries. AbbVie plans to use data from four clinical studies for tavapadon, acquired through the Cerevel Therapeutics deal, to seek further regulatory approvals.

FDA approves AbbVie's VYALEV for treating motor fluctuations in advanced Parkinson's disease, the first subcutaneous 24-hour levodopa-based infusion therapy.

FDA approves Vyalev, a 24-hour subcutaneous levodopa/carbidopa infusion for advanced Parkinson’s, aiming to reduce off episodes. Available in Canada, EU, and U.K., U.S. access depends on insurance, with Medicare coverage expected in 2H 2025. Vyalev's approval was based on Phase 3 trial results showing significant reduction in off time compared to oral therapy.