Horizon Pharma plc and Horizon Therapeutics Limited announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion at its plenary monthly meeting in September. They recommended a centralized marketing authorization for RAVICTI® (glycerol phenylbutyrate) Oral Liquid for use as an adjunctive therapy for chronic management of Urea Cycle Disorders (UCDs) in adult and pediatric patients greater than two months of age.
The European Commission (EC) will consider the adopted positive opinion for a binding decision, which will be issued for the granting of a centralized marketing authorization 60 to 90 days from the date of adoption of the opinion.
Impax Laboratories, Inc. announced that the CHMP of the EMA has adopted a positive opinion. They recommend that NUMIENT™ (IPX066), a modified-release oral capsule formulation of levodopa-carbidopa, be granted approval for the symptomatic treatment of Parkinson’s disease in adult patients.
The EC will now consider the CHMP positive opinion in its decision of whether to grant marketing authorization for NUMIENT in Europe. The review of this application is being conducted under the centralized licensing procedure as a therapeutic innovation, and the final decision will be applicable in all 28 member states of the European Union, as well as Iceland, Liechtenstein, and Norway.