NICE backs pump-based Parkinson’s drug from AbbVie

A therapy for Parkinson’s disease that can be delivered by a 24-hour subcutaneous infusion pump has been recommended for use by the NHS and could be an option for hundreds of patients with the neurodegenerative disease.

According to health technology assessment (HTA) organisation NICE, the therapy – AbbVie’s Produodopa (foslevodopa/foscarbidopa) – can be used only for patients in the later stages of Parkinson’s who have stopped responding to standard oral treatment.

Produodopa takes the form of a small and portable infusion pump that delivers the active ingredients over a 24-hour period and can be refilled at home by patients or their carers. It replaces the dopamine neurotransmitter that becomes deficient in Parkinson’s, leading to symptoms like tremor, stiffness, and slowness of movement, as well as mental health and cognitive problems.

While patients initially start taking oral drugs like levodopa and carbidopa to manage symptoms, these tend to lose their efficacy as the disease progresses and other therapies are added.

AbbVie asked for Produodopa to be considered for use in patients who cannot have apomorphine – an injectable drug that acts like dopamine to stimulate nerve cells – or deep brain stimulation surgery, or for people who stop responding to those therapies.

It is an alternative to another long-acting, non-oral product – levodopa–carbidopa intestinal gel (LCIG) – which is also sold by AbbVie under the Duodopa brand name. The latter is administered as a continuous infusion using a portable pump, via a percutaneous jejunostomy tube, which requires a surgical procedure to set up. NICE said around 900 patients could be eligible for the new treatment.

Formerly known as ABBV-951, Produodopa was approved by the MHRA last year, based on phase 3 data showing a statistically significant improvement in the time patients have their symptoms controlled over a 24-hour period, without troublesome dyskinesia, compared to oral immediate-release carbidopa/levodopa.

The drug’s progress in the US was held up earlier this year by a complete response letter (CRL) from the FDA seeking more information about the pump device, setting back a likely US launch until next year.

NICE approval for Produodopa is a boost to AbbVie’s aspirations for the product, which is viewed as a successor to Duodopa, which still brings in around $500 million-a-year in sales. Analysts have previously predicted that the Produodopa could eventually double that tally, thanks to its greater ease of use.

It could face competition, however, from other subcutaneous infusion therapies, notably Mitsubishi Tanabe Pharma’s ND-0612 (levodopa/carbidopa), which is in late-stage clinical testing.