Extended indication Treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Levodopa
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Parkinson's
Extended indication Treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
Proprietary name Inbrija
Manufacturer Acorda
Mechanism of action Neurotransmitter
Route of administration Inhalation
Therapeutical formulation Oral powder
Budgetting framework Extramural (GVS)
Additional remarks Precursor van dopamine.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
Submission date June 2018
Expected Registration September 2019
Orphan drug No
Registration phase Registration application pending
Additional remarks Nieuws september 2018: "Acorda Therapeutics, Inc today announced that the U.S. Food and Drug Administration (FDA) has extended its decision date on inhaled levodopa to January 5, 2019. According to a press release, the extension is related to submission of additional information on the drug’s chemistry and manufacturing that will take additional time for the FDA to review. "

Therapeutic value

Current treatment options Andere formuleringen van levodopa
Therapeutic value No judgement
Frequency of administration 5 times a day
References NCT02240030
Additional remarks SPAN-PD trial met primary endpoint: CVT-301 showed statistically significant improvement of motor function compared to placebo. In deze studie is het effect niet vergeleken met Sinemet.

Expected patient volume per year

References GIPdatabank
Additional remarks In 2016 waren er 35.925 gebruikers van levodopa/carbidopa (Sinemet). Afhankelijk van de meerwaarde zal Inbrija hier een deel van overnemen.

Expected cost per patient per year

Cost 800.00 - 900.00
References GIPdatabank
Additional remarks In 2016 werd er €859,70 per gebruiker van Sinemet vergoed.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.