FDA approves first-of-its-kind oral therapy for adults with Parkinson’s
New once-daily med Juvmo aims to maintain control of motor symptoms
Written by |
- The U.S. Food and Drug Administration has approved tavapadon, now known as Juvmo, to help better manage Parkinson's motor symptoms.
- The once-daily oral therapy, which uses a novel mechanism, is the first of its kind to win FDA approval, according to its developer.Â
- In clinical trials, Juvmo was shown to control motor symptoms and help delay the start of levodopa treatment.
The U.S. Food and Drug Administration (FDA) has approved tavapadon — an oral drug aimed at maintaining consistent control of motor symptoms — as a new treatment for adults with Parkinson’s disease.
The therapy’s developer, AbbVie, will market the once-daily med, taken as tablets, under the brand name Juvmo, according to a company press release. It’s expected to be commercially available in the U.S. in October. The newly approved therapy can be taken with or without levodopa treatment.
The company noted that Juvmo acts through a novel mechanism, making it the first therapy of its kind to receive FDA authorization for Parkinson’s.
“The approval of Juvmo marks the first dopaminergic breakthrough for Parkinson’s disease in decades,” said Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer at Abbvie.
According to the developer, Juvmo “offers patients a differentiated approach to motor symptom control across the Parkinson’s disease continuum.”
Parkinson’s is marked by the progressive loss of brain cells that produce dopamine, a key neurotransmitter, or brain signaling molecule, that helps control movement and emotion. Standard Parkinson’s treatment involves levodopa, which works to give the brain more raw material to make dopamine. However, as the disease progresses and more dopamine-making cells are lost, patients typically need increasingly higher levodopa doses, which can increase the risk of side effects.
Dopamine agonists — drugs that mimic the activity of dopamine — have also been used for years as part of Parkinson’s treatment. But most dopamine agonists now on the market target specific dopamine receptors, namely D2 and D3. Activating these receptors may help ease Parkinson’s symptoms, but this strategy can also cause side effects.
Juvmo acts on different targets than other Parkinson’s treatments
Juvmo is a dopamine agonist that acts on distinct receptors, known as the D1 and D5. Per Abbvie, this difference helps the therapy control motor symptoms for longer with fewer side effects.
“People living with Parkinson’s and the clinicians who care for them have long faced difficult tradeoffs between motor control, treatment burden and tolerability. Clinicians now have a new treatment option that targets dopamine pathways differently and reduces the difficult tradeoffs associated with D2/D3 selective dopamine agonists,” Thakkar said.
According to its developer, with the new FDA approval, Juvmo is now the first and only selective D1/D5 agonist available for Parkinson’s.
Abbvie’s application for Juvmo’s approval in the U.S. was based on data from a group of clinical trials, together called the TEMPO program. TEMPO-1 (NCT04201093) and TEMPO-2 (NCT04223193) tested the therapy against a placebo in adults with early-stage Parkinson’s who had minimal or no prior treatment. Meanwhile, TEMPO-3 (NCT04542499) tested Juvmo against placebo in more than 500 people with more advanced disease.
Across these studies, Juvmo was shown to be superior to the placebo in easing Parkinson’s symptoms and improving patients’ ability to function in day-to-day life. In patients with early disease, the therapy also helped delay the start of levodopa treatment. Long-term benefits of the therapy were maintained in an extension study called TEMPO-4 (NCT04760769), according to Abbvie.
People living with Parkinson’s and the clinicians who care for them have long faced difficult tradeoffs between motor control, treatment burden and tolerability. Clinicians now have a new treatment option that targets dopamine pathways differently.
“Parkinson’s disease treatment has long required health care providers to balance the need for dependable motor symptom control with considerations around treatment tolerability,” said Hubert Fernandez, MD, the global principal TEMPO trial investigator and a professor at the Cleveland Clinic Lerner College of Medicine. “Now we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides health care providers with greater flexibility to tailor treatment to individual patient needs.”
According to Juvmo’s prescribing information, common side effects include nausea, headache, dizziness, fatigue, dysgeusia, or an abnormal sense of taste, vomiting, and dry mouth. Anxiety also is common among people given the medication.
When Juvmo is used in combination with levodopa, common side effects include nausea, dyskinesia, or uncontrolled movements, dizziness, headache, and orthostatic hypotension, which is a sudden drop in blood pressure upon standing up. Hallucinations and psychotic-like behavior can also occur in people using both treatments, the label notes. There are no contraindications, or reasons not to use the therapy.
Michael J. Fox Foundation welcomes new treatment option
The treatment’s approval was welcomed by the Parkinson’s community.
“For people with Parkinson’s and their families, progress means having treatment options that deliver meaningful benefit in everyday life,” said Brian Fiske, PhD, chief scientist of The Michael J. Fox Foundation for Parkinson’s Research. “Each therapy approval is an important milestone in building a diverse treatment pipeline needed to meet the full range of unmet needs across the Parkinson’s community.”
Leave a comment
Fill in the required fields to post. Your email address will not be published.