Impax Laboratories has been granted by the European Commission (EC) authorization to market its Numient oral capsule formulation for the symptomatic treatment of adult patients with Parkinson’s disease.
Revealing the news on Wednesday, Impax noted that the review of this application was conducted under the centralized licensing procedure as a therapeutic innovation, and is applicable in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
Impax looking for partners to commercialize the drug outside U.S.
This is company’s first branded drug approved for commercialization outside the United States. Impax further said it was searching for partners across Europe and the rest of the world to commercialize the drug.
“We are pleased that Numient was approved by the European Commission as this not only showcases our R&D capabilities outside the US but is an additional positive review of our quality systems by another regulatory authority,” said Fred Wilkinson, President and Chief Executive Officer of Impax.
He said that Numient addresses one of the most significant unmet needs for patients living with this disease, which is to reduce the amount of time during the day when their symptoms are not adequately controlled.