The FDA has finally approved AbbVie’s infused Parkinson’s drug for patients who don’t respond to widely used oral therapies.
The drug, formerly known as ABBV-951, will be sold under the brand name Vyalev. It is a 24-hour continuous infusion of prodrugs of levodopa and carbidopa, two widely-used drugs in Parkinson’s treatment. It can provide another option for advanced Parkinson’s patients before more serious interventions.
Vyalev’s annual wholesale acquisition cost is approximately $119,000 per patient, an AbbVie spokesperson told Endpoints News.
The approval comes three years after Vyalev read out positive Phase 3 data, showing it succeeded on the primary endpoint of change in baseline “on” time without involuntary movements after 12 weeks. The average increase was 2.72 hours of “on” time for patients taking the drug, compared with 0.97 hours for those on standard of care, good for a p-value of p=0.0083.
Before Thursday’s approval, the program suffered two rejections: one in March 2023 after the FDA asked for more information about the therapy’s infusion pump device, and another in June after the FDA cited issues at a third-party manufacturing site.
The AbbVie spokesperson declined to comment on what the manufacturing issues were or what the company had done to resolve them.
Vyalev is administered through an infusion pump device that is designed to be portable and wearable. Ideally, advanced Parkinson’s patients would take the drug before receiving deep brain stimulation surgery, trial investigator Robert Hauser told Endpoints ahead of the June rejection. The effectiveness of levodopa and carbidopa wanes over time, leaving such individuals with few alternatives.
In addition to Vyalev, AbbVie could bring another Parkinson’s drug to market in the near future. Tavapadon, a program AbbVie acquired in its nearly $9 billion buyout of Cerevel Therapeutics, has succeeded in two Phase 3 trials this year looking at monotherapy and adjunctive settings. A third study is expected to read out by the end of the year.