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AbbVie’s Parkinson’s disease therapy application rejected by FDA

The regulator has requested more information on the pump used to administer ABBV-95


AbbVie has announced that its Parkinson’s disease therapy has not been approved by the US Food and Drug Administration (FDA), which has requested more information on the pump used to administer the treatment.

ABBV-95 is a combination of foscarbidopa and foslevodopa, the prodrugs for the commonly used carbidopa and levodopa (CD/LD).

The drug focuses specifically on treating motor fluctuations in adults with advanced stages of the disease and, unlike orally administered CD/LD, ABBV-95 is designed to be given continuously under the skin via a pump.

The company’s application was based on results from a phase 3 trial, in which the therapy significantly extended the time that patients did not experience involuntary movement, compared to orally administered CD/LD.

Approximately 130 adult participants with Parkinson's, whose motor symptoms were no longer adequately controlled by their current medications, were enrolled in the study at 80 sites in the US and Australia.

The submission was also supported by results from an ongoing multi-centre, phase 3, open-label study, assessing the long-term safety and efficacy of the therapy.

In its complete response letter, the FDA did not request additional efficacy and safety trials related to the drug, AbbVie outlined, adding that it soon plans to resubmit the marketing application.

Thomas Hudson, senior vice president, research and development, chief scientific officer at AbbVie, said: "There is an unmet need for people living with advanced Parkinson's disease as they face daily challenges in managing their condition.

"We will continue to work closely with the FDA as part of our commitment to bringing this treatment option to people impacted by this disease as quickly as possible."

Parkinson's disease is a progressive and chronic neurological disorder resulting from the loss of dopamine-producing brain cells, which primarily manifests with tremor, muscle rigidity, slowness of movement and difficulty with balance.

Nearly one million people in the US are living with the disease, according to the Parkinson’s Foundation, a number expected to rise to 1.2 million by 2030.

“Advanced Parkinson's disease causes unrelenting challenges and uncertainty for patients and caregivers worldwide," Hudson said at the time of the original submission, adding that the company recognises “the urgency for a new treatment that can enable better symptom control through the continuous 24-hour administration of medication".

Article by
Emily Kimber

23rd March 2023

From: Regulatory



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