Hemlibra

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On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Hemlibra, intended to prevent bleeding episodes in patients with haemophilia A who have factor VIII inhibitors. Hemlibra was reviewed under EMA’s accelerated assessment programme. The applicant for this medicinal product is Roche Registration Limited.

Hemlibra will be available as a solution for injection (30 mg/1 ml, 60 mg/0.4 ml, 105 mg/0.7 ml and 150 mg/1 ml). The active substance of Hemlibra is emicizumab (ATC code: B02BX), a bispecific monoclonal antibody that mimics the action of factor VIII, preventing bleeding in patients with haemophilia A who have decreased or no circulating levels of factor VIII.

The benefits with Hemlibra are its ability to reduce bleeds in routine prophylaxis with a weekly injection. The most common side effects are headache, injection site reaction, pyrexia, thrombotic microangiopathy, diarrhoea, arthralgia, and myalgia.

The full indication is: "Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A with factor VIII inhibitors. Hemlibra can be used in all age groups." It is proposed that Hemlibra should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Name Language First published Last updated
CHMP summary of positive opinion for Hemlibra (English only) 2018-01-26  

Key facts

Product details for Hemlibra
NameHemlibra
INN or common name

emicizumab

Therapeutic area Hemophilia A
Active substance

emicizumab

Date opinion adopted25/01/2018
Company name

Roche Registration Limited

StatusPositive
Application typeInitial authorisation