FDA Approves AbbVie's 24-Hour Parkinson's Infusion Therapy After Two Rejections

The FDA has officially approved AbbVie's new Parkinson's treatment, Vyalev, for patients who do not respond well to the commonly used oral medications. Previously referred to as ABBV-951, Vyalev is now available as a 24-hour continuous infusion of prodrugs levodopa and carbidopa, which are well-known in Parkinson's therapy. This new treatment provides an additional option for advanced Parkinson's patients, potentially delaying the need for more invasive procedures.

Vyalev has an annual wholesale acquisition cost of around $119,000 per patient, according to an AbbVie spokesperson. This approval follows three years after the drug achieved positive results in Phase 3 trials. The trials demonstrated that Vyalev met its primary endpoint by increasing the baseline "on" time without involuntary movements by an average of 2.72 hours, compared to just 0.97 hours for those on standard treatments, which is statistically significant with a p-value of 0.0083.

Despite the positive trial results, the path to approval was not straightforward. The FDA initially rejected Vyalev in March 2023, requesting more information about the therapy's infusion pump device. A second rejection followed in June due to issues at a third-party manufacturing site. AbbVie has not disclosed specific details regarding these manufacturing issues or how they were resolved.

Vyalev is designed to be administered through a portable, wearable infusion pump device, making it a practical option for patients with advanced Parkinson's disease. Robert Hauser, a trial investigator, noted that Vyalev could be used before patients undergo deep brain stimulation surgery. The effectiveness of levodopa and carbidopa tends to decrease over time, leaving patients with limited alternatives.

Besides Vyalev, AbbVie is also working on bringing another Parkinson's medication to the market. Tavapadon, which AbbVie acquired through its nearly $9 billion acquisition of Cerevel Therapeutics, has shown success in two Phase 3 trials this year, both as a monotherapy and in combination with other treatments. Results from a third study are anticipated by the end of the year.

Overall, Vyalev offers a promising new option for advanced Parkinson’s patients, addressing the need for continuous delivery of levodopa and carbidopa and filling a gap in the current treatment landscape.