NEWS RELEASE
November 16, 2022

Launch of Fintepla® (fenfluramine) for the Treatment of Seizures
Associated with Dravet syndrome in Japan

Kyoto, Japan, November 16, 2022 - Nippon Shinyaku Co., Ltd. (Nippon Shinyaku;Headquarters, Kyoto; President, Toru Nakai) announced today that it has launched Fintepla®
Oral Solution 2.2 mg/mL (ZX008; fenfluramine hydrochloride) for the treatment of seizures inpatients with Dravet syndrome (DS) in Japan.
UCB Japan Co. Ltd. (UCB Japan; Headquarters: Tokyo; President, Kanako Kikuchi) has
obtained marketing approval from the Ministry of Health, Labour and Welfare (MHLW), forFintepla® on 26 September, 2022.
Fintepla® is marketed by Nippon Shinyaku based on the exclusive distribution agreement
signed in 2019 between Zogenix, Inc. (acquired by UCB S.A. in 2022) and Nippon Shinyaku,
with UCB Japan taking responsibility as the manufacturer and distributor.
DS is a rare, devastating and life-long form of epilepsy that generally begins in infancy or
early childhood and is marked by frequent treatment-resistant seizures, frequent resulting
hospitalizations and medical emergencies, significant developmental and motor andbehavioral impairments. In Japan, DS has been designated as an intractable disease byMHLW, and there are estimated to be about 3,000 patients living with DS in Japan, based on
MHLW Patient Survey.
Fintepla® possesses dual activities to inhibit seizures: acting as a potent 5-HT (serotonin)releaser with agonist activity at several 5-HT receptors, and as a positive modulator of Sigma1 receptor. Fintepla® was designated as an orphan drug by MHLW for the indication of Dravet
syndrome in August, 2021.
Fintepla® is approved in the U.S. and Europe for the treatment of seizures associated withDS in patients two years of age and older. In the U.S., an additional indication of Fintepla®
for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two yearsof age and older was approved in March, 2022.
Nippon Shinyaku is focusing on the field of intractable, rare disorders. We hope that Fintepla®
will contribute to the treatment for patients suffering from DS in Japan.
1/3Product information

Brand nameFintepla® Oral Solution 2.2 mg/mL

Generic nameFenfluramine Hydrochloride

Date of approval

September 26, 2022

Date of NHI reimbursement

November 16, 2022

price listing
Date of launch

November 16, 2022

Manufacturer and Distributor

UCB Japan Co. LTD.

Distributor

Nippon Shinyaku Co., Ltd.

Indications and Usage

The treatment of seizures associated withDravet syndrome as an add-on therapy to antiepileptic medicines for the patients whose
seizures are not controlled by other anti-epileptic
medicines.

Dosage and administration

1.

Concomitant use with stiripentol
The usual oral dosage of fenfluramine for adults
and children 2 years of age and older is 0.2
mg/kg daily in two divided doses. The dosage
may be increased or decreased according tosymptoms to a daily dose not exceeding 0.4
mg/kg, but the dosage should be increased
after an interval of at least one week. The daily
dose should not exceed 17 mg.

2.

Without concomitant use of stiripentol:
The usual oral dosage of fenfluramine for adults
and children 2 years of age and older is 0.2
mg/kg daily in two divided doses. The dosage
may be increased or decreased according tosymptoms to a daily dose not exceeding 0.7
mg/kg, but the dosage should be increased after
an interval of at least one week. The daily doseshould not exceed 26 mg.

NHI reimbursement price

JPY 1,407.60/0.22%1mL

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About Nippon Shinyaku
Our mission is to help people lead healthier and happier lives. Through creating unique
medicines that will bring hope to patients and families struggling with illness, we aim to be anorganization trusted by the community. Please visit our website (https://www.nipponshinyaku.co.jp/english/index.php) for products or detailed information.
About UCB JapanUCB Japan (https://www.ucbjapan.com/) was established in 1988 as the Japanesesubsidiary of UCB S.A., a global biopharmaceutical company headquartered in Brussels,Belgium. The company is developing its pharmaceutical business with a focus on antiepileptic drugs, rheumatoid arthritis and psoriasis drugs. As a biopharmaceutical leader increating value for patients, the company aims to provide new treatment options for patients
who have not achieved satisfactory improvement with conventional therapies.
Contact
Corporate Communications Dept., Nippon Shinyaku
FAX: +81-75-321-9128

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