AbbVie has introduced Produodopa (foslevodopa/ foscarbidopa) to treat patients with certain types of advanced Parkinson’s disease (PD) in the European Union (EU).
Produodopa is a solution of levodopa and carbidopa prodrugs. It is said to be the first and only subcutaneous 24-hour infusion levodopa-based therapy for PD.
AbbVie has launched the solution to treat PD with severe motor fluctuations and hyperkinesia or dyskinesia when existing combinations of Parkinson’s medicinal products have not delivered positive results.
The US-based pharmaceutical company received marketing authorisation of Produodopa via the Decentralised Procedure in Q3 2022.
Vyafuser pump for the subcutaneous delivery of the solution secured a CE mark in November last year.
The product launch was based on results from three studies, the Phase 3, 12-month open-label M15-741 study, the Phase 3, 12-week M15-736 study and a Phase 1 pharmacokinetic comparability study.
According to the findings from the M15-741 trial, Produodopa demonstrated a favourable benefit/risk profile along with sustained improvements in ‘Off’ time and ‘On’ time without dyskinesia and morning akinesia.
AbbVie development and regulatory affairs SVP and chief medical officer Roopal Thakkar said: “People living with Parkinson’s disease experience daily challenges and uncertainty, especially as their disease progresses and symptoms are no longer adequately controlled.
“This approval is an example of our unwavering commitment to this community by developing new, transformative therapeutic options for people experiencing advanced Parkinson’s disease, their families, and care partners.”
In a separate development, US-based ConcertAI and Caris Life Sciences signed a multi-year collaboration with AbbVie.
Both firms will work to support AbbVie’s precision medicine-driven research and development work and optimise oncology clinical trials.
Under the terms of the agreement, the American pharmaceutical firm will be able to use ConcertAI’s research-grade clinical data across a variety of cancer types.
AbbVie will also leverage Caris’ expansive real-world, multi-modal oncology database to support the development of new therapies.
Through the collaboration, the company will also be able to optimise oncology trials and patient enrolment by using ConcertAI, Caris’ clinical network, and laboratory capabilities combined with artificial intelligence/ machine learning.
