- AbbVie said Friday it has officially asked the Food and Drug Administration to approve a treatment meant to keep symptoms of Parkinson's disease in check for longer than currently available therapies.
- AbbVie's medicine combines two chemicals, called carbidopa and levodopa, that are mainstay Parkinson's treatments. Importantly, though, it uses prodrug versions of each chemical — meaning the therapeutic effect doesn't kick in until the body metabolizes them. AbbVie says this design, coupled with delivery via a shot, can provide continuous, 24-hour delivery of carbidopa and levidopa.
- The company based its approval application on a late-stage clinical trial that found its prodrug combination was significantly better than oral, immediate-release carbidopa and levodopa at controlling motor fluctuations in advanced Parkinson's patients. AbbVie is currently sponsoring an open-label extension study to evaluate the long-term safety and efficacy of its medicine.
Estimates hold that Parkinson's affects around 1 million people in the United States, making it one of the most common neurodegenerative disorders.
It's characterized by the progressive loss of brain cells that produce dopamine, a chemical which is essential for cellular communication and body movement. Patients typically experience tremors, stiff muscles, and slowed or impaired mobility — symptoms that get worse as the disease advances.
Like many brain conditions, Parkinson's can be difficult to manage, particularly over time as symptoms advance. The FDA has approved several drugs to address symptoms of the disease, including more recent additions like Xadago from Newron Pharmaceuticals and Ongentys from Neurocrine Biosciences.
Both Xadago and Ongentys are used as add-ons to levodopa and carbidopa, the most frequently prescribed Parkinson's drugs. While effective, levodopa and carbidopa aren't very durable, with effects lasting roughly two to six hours depending on whether they're formulated as immediate-release or extended-release versions.
For AbbVie and others, one goal has been to prolong the effects of these two drugs. Doing so could provide quality of life improvements for patients as well as lucrative new products for developers. AbbVie, for instance, expects peak annual sales of its prodrug medicine, which it calls ABBV-951, to eventually surpass $1 billion.
AbbVie's decision to submit its prodrug comes one month after it ended a research alliance with the Swedish biotechnology company BioArctic. Together, the partners were hoping to develop an antibody-based therapy targeting a protein that researchers believe is tied to Parkinson's and other related dementias.
BioArctic isn't the only Parkinson's collaboration that didn't work out for AbbVie. In 2020, the company terminated a deal with Voyager Therapeutics that also aimed to create antibody treatments for the disease.