Green light for new medicines

EMA Highlights by Gary Finnegan – The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of marketing authorisations for several new products. This opinion must be formally endorsed by the European Commission before coming into effect. The following medicines received the CHMP seal of approval:

–         Tecfidera (dimethyl fumarate) from Biogen Idec Ltd. is intended for the treatment of adult patients with relapsing remitting multiple sclerosis. It comes in 120mg and 240mg gastro-resistant hard capsules and primarily acts by triggering the activation of the Nrf2 transcriptional pathway.

–         Stribild from Gilead Sciences International Ltd. is intended for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV 1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild. The drug comes in 150mg, 200mg and 245mg film-coated tablets and contains elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil. Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI), cobicistat enhances the systemic exposure of elvitegravir, emtricitabine is a nucleoside analogue of cytidine and tenofovir, is a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate. The benefits with Stribild are its ability to reduce the viral load to undetectable levels (< 50 HIV-1 RNA copies/ml.

–         Iclusig (ponatinib) from ARIAD Pharma Ltd. comes in 15mg and 45 film-coated tablets intended for the treatment of chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Iclusig was designated as an orphan medicinal product in February 2010. Its active substance is ponatinib, a protein kinase inhibitor which acts by inhibiting the BCR-ABL kinase. The benefits of Iclusig are its cytogenetic and haematological response rates in patients with CML and Ph+ ALL including patients bearing T315I mutation.

–         HyQvia from Baxter Innovations GmbH comes as a 100mg/ml solution for infusion for subcutaneous use. It is human normal immunoglobin intended for replacement therapy in adults in primary immunodeficiency syndromes such as congenital a congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiency; IgG subclass deficiencies with recurrent infections; and as replacement therapy in adults (> 18 years) in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.