The FDA’s recent approval of AbbVie’s new combination therapy provides patients with longer-lasting control of movements.
As described recently in Biopharmadive, Parkinson’s disease is characterized by uncontrolled muscle movements or stiffness caused by the progressive breakdown and death of nerve cells.
About Vyalev
Recently approved, Vyalev uses a unique method of pairing levodopa and carbidopa. The drugs are delivered as a continuous subcutaneous (under the skin) infusion to treat motor fluctuations in patients with Parkinson’s that is in the advanced stages. The therapeutic benefit is not felt until the drugs have been absorbed.
In addition, Vyalev is the only therapy that is levodopa-based and administered, similar to insulin pumps, on a twenty-four-hour basis. This feature may be especially useful if patients have difficulty swallowing pills.
Robert Hauser M.D., Florida University’s Director of the Parkinson’s Center for movement disorders explained that the progressive nature of Parkinson’s eventually renders medications ineffective and surgical treatment may be necessary. Dr. Hauser stated that the newly approved non-surgical treatment provides 24-hour continuous levodopa delivery.
Over two years ago AbbVie applied to the FDA for approval but was denied twice before receiving its recent approval. The company acknowledged the FDA’s objections but noted that neither of the denials pertained to AbbVie directly. The first denial pertained to a request by the FDA for additional information on the pump that is used to administer the product. The second denial was based on the FDA’s concern with respect to a manufacturer that was listed in AbbVie’s approval application. Once the issues were resolved, the FDA moved forward and made a decision to grant approval according to the results of two clinical trials.
One of the trials involved 174 participants diagnosed with late-staged Parkinson’s. The investigators compared Vyalev against a fast-acting tablet of carbidopa and levodopa. The patients who were treated with AbbVie’s drug showed substantial improvement in motor function and longer periods of relief from symptoms.
The second trial involved a one-year study period. During that time rather than a placebo, all participants in that group were notified that they were receiving Vyalev, the investigational drug.
Now that Vyalev has been approved, attention is turned towards patients’ insurance coverage. Access to the drug depends upon an individual’s plan. Medicare, however, is expected to provide coverage in the latter part of 2025.
AbbVie scored an earlier approval this year for its newly acquired Parkinson’s drug tavapadon. The drug was part of AbbVie’s $9 billion acquisition with Cerevel therapeutics.
Reports show that tavapadon was an improvement over a placebo at lengthening the time symptoms were controlled and suppressing motor functions.
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