AbbVie's Cerevel takeover delivers Parkinson's approval

The first product from AbbVie's $8.7 billion takeover of Cerevel two years ago – Parkinson's disease therapy tavapadon – has been approved by the FDA.

The once-daily oral drug, a partial dopamine D1/D5 receptor agonist, has been cleared under the Juvmo brand name to treat adults with Parkinson's, according to the FDA website. AbbVie had filed for approval of a broad label claim for the drug, which can be used as a monotherapy or in combination with levodopa, the go-to Parkinson's therapy.

Juvmo is an alternative to older dopamine agonists that target D2/D3 receptors, like pramipexole and ropinirole, and is designed to reduce the risk of side effects like impulse control disorders and excessive daytime sleepiness.

The approval will be a big relief for AbbVie, which said that Pfizer spinout Cerevel's pipeline of central nervous system therapies had multibillion-dollar sales potential when the acquisition closed. Since then, it has suffered a setback with schizophrenia drug candidate emraclidine, which failed to show efficacy in a phase 2 trial, prompting a $3.5 billion impairment charge.

Emraclidine is still being explored in schizophrenia as well as for other forms of psychosis, but the outcome raised the importance of tavapadon for AbbVie, alongside other candidates from Cerevel's pipeline such as GABA-targeting darigabat, which has reached phase 2 for treatment-resistant epilepsy.

AbbVie's filing for Juvmo was based mainly on the TEMPO-1 and TEMPO-2 trials as a monotherapy in early Parkinson's, TEMPO-3 as a combination with levodopa in patients still experiencing motor fluctuations, and the long-term safety study TEMPO-4.

TEMPO-1 and TEMPO-2 showed that patients saw a statistically significant improvement from baseline in the MDS-UPDRS rating scale at week 26. Meanwhile, TEMPO-3 demonstrated that patients experienced more 'on' time, referring to the period when symptoms were well controlled without involuntary movements and troublesome dyskinesia side effects.

While patients with Parkinson's initially start taking drugs like levodopa to manage symptoms, these often fail to control symptoms throughout a 24-hour period and tend to lose their efficacy as the disease progresses, leading to periods of 'off' time when symptoms like tremor, stiffness, and slowness of movement occur.

Analysts have suggested that Juvmo could make sales upwards of $1 billion a year, part of a Parkinson's franchise that AbbVie thinks could generate $5 billion a year at peak. Its other drugs include Vyalev/Produodopa (foslevodopa/foscarbidopa), a subcutaneous 24-hour continuous infusion, which is on track to breach the $1 billion sales threshold this year.

AbbVie has been reticent on its sales expectations for Juvmo, but has pointed to the drug's ability to address the huge oral market in Parkinson's – around 85% of the total – and its side-effect profile that could drive uptake as a monotherapy, particularly in younger patients who are at risk of developing dyskinesias with protracted levodopa or carbidopa therapy.

Image by Annick Vanblaere via Pixabay