Lenvatinib

Extended indication	Treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, in adolescents and adults 12 years or older.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Leniolisib
Domain	Chronic immune diseases
Reason of inclusion	New medicine (specialité)
Main indication	Other chronic immune diseases
Extended indication	Treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, in adolescents and adults 12 years or older.
Manufacturer	Pharming
Portfolio holder	Novartis
Route of administration	Oral
Therapeutical formulation	Capsule

Registration route	Centralised (EMA)
Type of trajectory	Accelerated assessment
ATMP	No
Submission date	November 2022
Expected Registration	August 2023
Orphan drug	Yes
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet
Duration of treatment	continuous
Frequency of administration	2 times a day
Dosage per administration	10-70 mg
References	NCT02435173

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.