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Thrombomodulin alfa

Recomodulin

Extended indication Septic shock (Sepsis) - with disseminated intravascular coagulation (DIC)
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Thrombomodulin alfa
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other non-oncological hematological medications
Extended indication Septic shock (Sepsis) - with disseminated intravascular coagulation (DIC)
Proprietary name Recomodulin
Manufacturer Asahi Kasei
Mechanism of action Anticoagulant
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Recombinant Human Thrombomodulin.

Registration

Registration route Centralised (EMA)
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials
Additional remarks Nov 18: The phase III trial (NCT01598831) is still recruiting pts, with an estimated study completion date of Dec 2019 (SPS)

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 0,06 mg/kg tot max 6 mg
References NCT01598831

Expected patient volume per year

Patient volume

< 2,250

Market share is generally not included unless otherwise stated.
References https://www.ntvg.nl/artikelen/sepsis-een-gecompliceerd-syndroom-met-belangrijke-medische-en-maatschappelijke/volledig;
Additional remarks In Nederland worden naar schatting jaarlijks circa 9.000 patiënten op de Intensive Care opgenomen met ernstige sepsis. De inschatting is dat hiervan een kwart mogelijk een septische shock krijgt en (het maximale patiëntenaantal dat in aanmerking komt voor deze behandeling).

Expected cost per patient per year

There is currently nothing known about the expected cost.

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

Indication extension Yes
Indication extensions Phase 3: Idiopathic pulmonary fibrosis
References Adis Insight

Other information

There is currently no futher information available.