Tuesday, April 16, 2024

Innovative Subcutaneous Infusion Therapy for Parkinson’s Disease Gains NHS Approval

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A groundbreaking therapy for Parkinson’s disease, capable of being administered through a 24-hour subcutaneous infusion pump, has received a recommendation for use within the NHS. This therapy, AbbVie’s Produodopa (foslevodopa/foscarbidopa), could potentially benefit numerous patients grappling with this neurodegenerative condition.

The endorsement from the National Institute for Health and Care Excellence (NICE) specifies that Produodopa is suitable for patients in the advanced stages of Parkinson’s who no longer respond to conventional oral treatments.

Produodopa employs a compact and portable infusion pump that disburses active ingredients continuously over 24 hours. Patients or their caregivers can conveniently refill the pump at home. This therapy replenishes the deficient dopamine neurotransmitter, addressing the symptoms associated with Parkinson’s, such as tremors, rigidity, slowed movements, and cognitive issues.

In the initial stages of the disease, patients often rely on oral medications like levodopa and carbidopa to manage symptoms. However, as Parkinson’s progresses, these drugs tend to lose their effectiveness, necessitating the exploration of alternative therapies.

AbbVie sought approval for Produodopa as an option for patients who cannot receive apomorphine (an injectable dopamine-like drug) or deep brain stimulation surgery or for those who cease responding to these treatments.

Produodopa presents an alternative to another non-oral, long-acting product – levodopa-carbidopa intestinal gel (LCIG) – also marketed by AbbVie under the brand name Duodopa. LCIG is administered as a continuous infusion via a portable pump through a percutaneous jejunostomy tube, a method that requires a surgical procedure for setup. NICE estimates that approximately 900 patients could qualify for the new treatment.

Previously known as ABBV-951, Produodopa gained approval from the MHRA last year based on phase 3 data demonstrating a statistically significant enhancement in the duration patients experienced symptom control over 24 hours without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa.

In the United States, the drug’s progress faced delays earlier this year due to a complete response letter (CRL) from the FDA requesting more information about the pump device, postponing a likely US launch until the following year.

NICE’s approval of Produodopa represents a significant milestone for AbbVie, positioning the product as a successor to Duodopa, which still generates approximately $500 million in annual sales. Analysts have previously projected that Produodopa’s greater user-friendliness could potentially double this figure.

However, it may encounter competition from other subcutaneous infusion therapies, notably Mitsubishi Tanabe Pharma’s ND-0612 (levodopa/carbidopa), currently in late-stage clinical trials.

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