AbbVie ABBV announced that the FDA has approved its subcutaneous administered drug ABBV-951 to treat motor fluctuations in adult patients with advanced Parkinson's disease (PD). The drug will be marketed under the trade name Vyalev.
Vyalev is a solution of carbidopa (CD) and levodopa (LD) prodrugs, which are the standard of care for PD patients. Prodrugs are medications that become active once they enter the body. The drug has been designed to offer continuous subcutaneous delivery of CD/LD prodrugs through a pump device and improve patient experience.
Following this approval, Vyalev has become the first and only 24-hour continuous infusion of levodopa-based therapy to treat the given indication. The drug has already been launched for similar use in 34 countries, including Europe and Japan, where it is marketed under the trade name Produodopa.
The drug’s coverage for Medicare patients is expected in the second half of next year.
ABBV Secures Nod After Multiple Regulatory Setbacks
The latest FDA approval is based on data from a pivotal phase III study which showed that treatment with Vyalev demonstrated a superior improvement in motor fluctuations, with increased "On" time without troublesome dyskinesia when compared to orally administered CD/LD.
Per management, "On" time is cited as the period when symptoms are well controlled without dyskinesia or involuntary movements. The goal of PD patients and physicians is to extend the amount of "On" time.
This approval came two years after AbbVie submitted the regulatory filing for the drug for the first time. In between, the agency refused to approve the drug twice. The first rejection was received in March 2023 where it asked for extra information about the pump device used to administer the medicine. ABBV received the second rejection this year in June based on the FDA’s observations from an inspection of one of AbbVie's third-party manufacturing facilities listed in the drug application. In both these cases, the FDA did not request any additional efficacy/safety study on the drug.
ABBV Stock Performance
Year to date, AbbVie’s shares have moved up 21.7% compared with the industry’s 20.7% growth.
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Second Success for ABBV Stock in PD Space Under a Month
The FDA’s approval of Vyalev came just a few weeks after management announced positive top-line results from the pivotal III TEMPO-1 study, which evaluated its recently acquired investigational drug tavapadon in adults with early PD. The study achieved its primary endpoint — patients who received two fixed doses (5mg and 15mg) of once-daily tavapadon for 26 weeks achieved statistically significant improvement in disease burden.
The TEMPO-1 study is one of the four clinical studies in the late-stage TEMPO clinical development program, which is evaluating tavapadon across a broad PD population. Earlier this year, ABBV reported data from the late-stage TEMPO-3 study that evaluated the drug as an adjunctive therapy to LD in adult patients with PD. The study met its primary endpoint — the drug, when used as an add-on to LD, improved symptom control.
AbbVie also plans to report data from the phase III TEMPO-2 study, which is evaluating flexible doses of the drug in early PD patients, by this year’s end. The fourth study, named TEMPO-4, is an open-label extension study to assess the long-term safety and tolerability of the drug in PD patients.
Management intends to use the data from all the above studies when it seeks regulatory approval for tavapadon in PD indication. The drug was added to AbbVie’s pipeline following the acquisition of Cerevel therapeutics for around $8.7 billion, completed in August.
Through the above acquisition, ABBV aims to strengthen its neuroscience pipeline by adding Cerevel’s novel pipeline candidates being studied across a range of psychiatric and neurological disorders, which also include schizophrenia and mood disorders. Apart from tavapadon, the Cerevel acquisition also added some other promising neuroscience pipeline candidates to the company’s pipeline, like emraclidine (in phase II studies for schizophrenia) and darigabat (in phase II studies for epilepsy and panic disorder).
ABBV’s Zacks Rank
AbbVie currently carries a Zacks Rank #3 (Hold).
AbbVie Inc. Price
AbbVie Inc. price | AbbVie Inc. Quote
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