FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

MHRA: Benefits Outweigh Risks for Roche’s Hemophilia Drug

Jan. 8, 2018

The UK’s Medicines and Healthcare products Regulatory Agency issued a positive scientific opinion on Roche’s hemophilia drug emicizumab.

The MHRA wrote that use of the drug in patients with and without previous immune tolerance induction experience showed it cuts treated bleeds by nearly 90 percent after 24 weeks of treatment, leading to improved quality of life across all age groups.

The agency found the drug’s risks were “tolerable.” The top safety concerns were increased thromboembolic events or thromboembolic microangiopathy, which occurred in four of 189 patients.

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