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Chugai's Hemlibra Gains Positive CHMP Opinion in Severe Hemophilia a Without Inhibitors.

M2 PHARMA-February 4, 2019-Chugai's Hemlibra Gains Positive CHMP Opinion in Severe Hemophilia a Without Inhibitors

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- Swiss health care group Roche (SIX: RO) (OTCQX: RHHBY) has received notification that the EU Committee for Medicinal Products for Human Use adopted a positive opinion for Hemlibra, a treatment for hemophilia A created by Japanese drugmaker Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519), for routine prophylaxis of bleeding episodes in adults and children with severe hemophilia A without factor VIII inhibitors, administered once weekly, every two weeks, or every four weeks, Chugai said.

The CHMP has also adopted a positive opinion for additional dosing options of every two weeks or every four weeks in adults and children with hemophilia A with factor VIII inhibitors.

This positive opinion is based on results from two Phase III studies HAVEN 3 (NCT02847637) and HAVEN 4 (NCT03020160), conducted jointly with Roche and Genentech.

HAVEN 3 study was conducted to evaluate the reduction of bleed rate of Hemlibra subcutaneous injection once a week and once every two weeks in people with hemophilia A (12 years of age or older) without inhibitors to factor VIII.

HAVEN 4 study was conducted to evaluate efficacy, safety, and pharmacokinetics of Hemlibra subcutaneous injection every four weeks in people with hemophilia A (12 years of age or older), with and without inhibitors to factor VIII.

In Japan, Chugai obtained regulatory approval for Hemlibra from the Ministry of Health, Labour and Welfare in December 2018 for an additional indication of prophylactic treatment for people with hemophilia A without inhibitors to factor VIII, as well as for additional dosage and administration as a biweekly or every four-week treatment for people with hemophilia A with inhibitors to factor VIII.

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Publication:M2 Pharma
Date:Feb 4, 2019
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