EMA approves 5 new drugs in Europe, others not so lucky

March 22, 2013 | By Márcio Barra

EMA’s CHMP 18 – 21 March meeting was fruitful, with 5 new drugs attaining marketing authorization (MA), 2 MA applications denied, 3 new generics MAs approved, 4 drugs seeing their therapeutic indications extended, and 2 companies giving up on their MA application. Here’s the rundown approvals and refusals:

Approved marketing authorizations for new drugs

Aubagio (teriflunomide), Sanofi-aventis – A selective immunosuppressant, with anti-inflammatory properties for the treatment of multiple sclerosis.

HyQvia (human normal immunoglobulin), Baxter Innovations GmbH – A replacement therapy for adults with primary immunodeficiency syndromes such as:

  • congenital agammaglobulinaemia and hypogammaglobulinaemia
  • common variable immunodeficiency
  • severe combined immunodeficiency
  • IgG subclass deficiencies with recurrent infections

Iclusig (ponatinib), Ariad Pharma Ltd – A protein kinase inhibitor (L01XE24) that acts through inhibition of the BCR-ABL kinase.

Stribild (elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil), Gilead Sciences, Inc. – A combination antiviral for treatment of HIV infections, containing the following active substances:

  • Elvitegravir, an HIV-1  integrase strand transfer inhibitor (INSTI)
  • Cobicistat, which enhances the systemic exposure of elvitegravir
  • Emtricitabine, a nucleoside analogue of cytidine
  • Tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate.

Tecfidera (dimethyl fumarate), Biogen Idec Ltd – A drug for the nervous system that  primarily acts by activating the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway, for the treatment of relapsing remitting multiple sclerosis.

Denied marketing authorizations of new drugs

Defitelio (defibrotide), Gentium SpA – An orphan drug,for the treatment and prevention of hepatic veno-occlusive disease in blood stem cell transplantation therapy. It’s MA was refused on the basis of insufficient evidence of the medicine´s benefit, alongside some doubts on the way the efficacy study was designed.

Labazenit (budesonide / salmeterol), Laboratoires SMB S.A. – A combination drug for asthma, containing Budesonide, a corticosteroid that works as an anti-inflammatory agent, and salmeterol, a long-acting beta-2 agonist. These drugs are commonly found in other products either alone or in combination for the treatment of asthma. It was refused as the study comparing Labazenit with budesonide alone did not show satisfactory efficacy.

Approved marketing authorizations for new generics

Memantine ratiopharm (memantine hydrochloride), Ratiopharm GmbH – A psychoanaleptic antidementia drug, that acts through antagonism of the N-methyl-D-aspartate (NMDA) receptor, controlling the elevated levels of glutamate that may lead to neuronal dysfunction.

Stayveer (bosentan monohydrate), Marklas Nederland BV – An anti-hypertensive drug and endothelin receptor (ETa and ETb) antagonist, which decreases pulmonary vascular resistance. It is used for the treatment of pulmonary arterial hypertension.

Voriconazole Accord (voriconazole), Accord Healthcare Ltd – A broad spectrum, triazole antifungal agent, that works by inhibiting an essential step in fungal ergosterol biosynthesis.  It is for the “Treatment of invasive aspergillosis, treatment of candidemia in nonneutropenic patients, treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei), and treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.”

Approved extensions for new therapeutic indications of existing drugs

Mabthera (rituximab), Roche Registration Ltd – This drug is currently used for the treatment of Non-Hodgkin’s lymphoma (NHL), Chronic lymphocytic leukaemia (CLL) and Rheumatoid arthritis. The new approved extension is for granulomatosis with polyangiitis and Microscopic polyangiitis.

Soliris (eculizumab), Alexion Europe SAS – Aka the world’s most expensive drug, priced at more than $409,000 per year, used for the treatment of paroxysymal nocturnal hemoglobinuria in adults only, and atypical haemolytic uremic syndrome (aHUS) in adults and children. The new indication is an extension of the paroxysmal nocturnal haemoglobinuria indication to include children.

Viread (tenofovir disoproxil fumarate), Gilead Sciences International Ltd – For the treatment of Hepatitis B infection. Now it is also indicated for the treatment of chronic hepatitis B in adults with evidence of lamivudine-resistant hepatitis B virus.

Xarelto (rivaroxaban), Bayer Pharma AG – Therapeutic indication for a new 2.5mg dose was approved. It is “for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers”, either “co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel  or ticlopidine”

Applications withdrew

Fanaptum (iloperidone), Vanda Pharmaceuticals Ltd – A drug for treatment of schizophrenia in adults. The company withdrew the application because the CHMP identified missing data, which Vanda could not make available within the regulatory timeframe.

OraNera (autologous oral mucosal epithelial cells), CellSeed Europe Ltd – A cell therapy intended for the treatment of limbal stem cell deficiency in adults. The application was withdrawn on the basis of the CAT’s preliminary assessment, as the committee could not agree on a positive benefit-risk balance for the therapy and the company could not bring additional information in an acceptable timeframe.

Sources :

EMA

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