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EMA advisors back eight medicines for approval



Eight medicines have been backed for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use, including new therapies to treat hepatitis C, multiple sclerosis and cancer.

Marketing recommendations were issued for two drugs - AbbVie’s Maviret (glecaprevir/pibrentasvir) and Gilead Science’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir) - that target chronic hepatitis C infection, both reviewed under the EU’s accelerated assessment mechanism.

HCV infection is considered a major public health challenge, with around 15 million people chronically infected across the UK and the disease representing the most common single cause of liver transplantation in the region.

Both Maviret and Vosevi are active against all genotypes of the virus and may be specifically useful in some patients who failed or cannot use previously available therapies.

Two cancer medicines received a positive opinion from the CHMP: Novartis’ Kisqali (ribociclib) for the treatment of locally advanced or metastatic breast cancer and Eusa Pharma’s Fotivda (tivozanib) for the treatment of advanced renal cell carcinoma.

Kisqali is a protein kinase inhibitor that selectively inhibits cyclin-dependent kinase (CDK) 4 and 6, which are known to be involved in processes leading to cellular proliferation, while Fotivda is a protein kinase inhibitor which, by blocking vascular endothelial growth factor receptors, inhibits angiogenesis leading to inhibition of tumour growth.

Elsewhere, Merck Serono’s Mavenclad (cladribine) was backed as a treatment of relapsing forms of multiple sclerosis. The drug is an antimetabolite that depletes lymphocytes by causing DNA strand breaks and interfering with DNA synthesis, able to reduce the frequency of relapses and delay disease progression, the CHMP noted.

The Committee also recommended Samsung Bioepis’ Humira biosimilar Imraldi (adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and uveitis, as well as generics Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan(efavirenz/emtricitabine/tenofovir disoproxil) for the treatment of HIV infection and Nitisinone Mendeli KABS (nitisinone) for the treatment of hereditary tyrosinemia type 1.

Source: Pharmatimes

http://www.pharmatimes.com/news/ema_advisors_back_eight_medicines_for_approval_1197135

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