NeuroDerm has announced that the European Medicines Agency (EMA) has deemed ND0612H, its product candidate offering continuous delivery of levodopa/carbidopa (LD/CD) treatment for advanced Parkinson’s disease, eligible for a European Union marketing authorisation application procedure (“centralised procedure”). According to EMA guidelines, the EMA can allow products for which the centralised procedure is not mandatory to use that procedure, if the EMA considers that it constitutes a significant therapeutic, scientific or technical innovation.
ND0612H is a high-dose form of liquid LD/CD drug delivered continuously through subcutaneous administration by a belt pump. ND0612H is designed to significantly reduce motor complications in advanced Parkinson’s disease patients by maintaining steady, high levodopa plasma levels in a convenient manner, to replace current treatments that require highly invasive surgery associated with serious side effects.
“The eligibility for the centralised procedure in the European Union confirms the innovation underlying ND0612H,” says Oded Lieberman, NeuroDerm’s chief executive officer. “It also means that ND0612H will be able to benefit from the more streamlined access to the EU market inherent in this regulatory route. NeuroDerm wishes to bring ND0612H into the market as quickly as possible and make a dramatic change in the lives of Parkinson’s disease patients.”
ND0612L, NeuroDerm’s low dose drug form for moderate stage Parkinson’s patients, has successfully completed phase I and IIa studies. It is currently undergoing a phase II double-blind, randomised, placebo-controlled study supported by a grant from The Michael J Fox Foundation for Parkinson’s Research.