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Jun 27, 2014

CHMP Recommends European Approval of Six Drugs

  • The European Medicines Agency’s Committee for Medicinal Products for Human Use yesterday wrapped up its June meeting by recommending approval by the European Union of six new medicines.

    CHMP issued one of its positive opinions to Eli Lilly and Boehringer Ingelheim for their LY2963016, a new insulin glargine product also known as Abasria and indicated for the treatment of type 1 and type 2 diabetes.

    LY2963016—the first biosimilar insulin recommended for approval in the E.U.—is a basal insulin intended to provide long-lasting blood sugar control between meals and at night. The compound has the same amino acid sequence as Lantus® (insulin glargine) and was filed through EMA’s biosimilar pathway.

    The Bristol-Myers Squibb (BMS) drug candidate Daklinza®, (daclatasvir), a treatment for chronic hepatitis C virus (HCV) in adults, won a CHMP positive opinion for use in combination with other medicinal products. Daklinza—which underwent an accelerated review process because it meets an unmet medical need—is the first pan-genotypic NS5A complex inhibitor to be recommended for approval by CHMP.

    CHMP cited results of a pivotal trial in which Daklinza was evaluated in HCV genotype-1, -2 and -3 infected patients, in combination with sofosbuvir with or without ribavirin. The study included a treatment arm with patients that previously failed on therapy with an NS3/4A inhibitor in combination with pegylated interferon and ribavirin. All such patients reached a sustained virologic response. The pivotal trial was supported by an earlier study of Daklinza in combination with pegylated interferon and ribavirin in patients with genotype 4 infection, and by several phase IIb trials of Daklinza with other combinations including with pegylated interferon and ribavirin.

    Applications for Daklinza-based treatment regimens are also pending in Japan and the U.S. BMS said a decision from Japan's Pharmaceutical and Medical Devices Agency is expected soon. The FDA has granted priority review status and set a target review date under the Prescription Drug User Fee Act (PDUFA) of Nov. 30, 2014.

    Viiv Healthcare’s Triumeq® (dolutegravir/abacavir/lamivudine) won a CHMP recommendation of approval for the treatment of HIV infection in adults and adolescents, aged 12 years and older and weighing at least 40kg (88 pounds). Triumeq is a once-daily single-tablet regimen, combining the integrase inhibitor dolutegravir—itself approved by the EMA in January 2014 under the brand name Tivicay®—and the nucleoside analogues abacavir/lamivudine.

    CHMP’s decision was based on data from two pivotal studies: The Phase III SINGLE study of dolutegravir, conducted with dolutegravir and abacavir/lamivudine as separate pills; and a separate bioequivalence study of the fixed-dose combination of dolutegravir/abacavir/lamivudine when taken as a single tablet compared to the administration of dolutegravir and abacavir/lamivudine as separate pills.

    The FDA is reviewing an NDA submitted in October 2013 for abacavir/dolutegravir/lamivudine. Regulatory reviews are also in progress in Canada, Australia, Brazil and Japan.

    Viiv is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer. Shionogi joined as a 10% shareholder in October 2012.

    A joint venture of Vifor Pharma, Galenica and Fresenius Medical Care won a CHMP positive opinion for Velphoro® (sucroferric oxyhydroxide). The mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches was approved for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).

    Velphoro’s benefits include its ability to reduce serum phosphorus in patients on maintenance dialyses with an acceptable safety profile based on data up to one year. The most common side effects are abnormal product taste and gastrointestinal disorders—of which the vast majority occurred early during treatment and abated over time with continued dosing, according to the EMA.

    Velphoro was approved by the FDA in November 2013 for the control of serum phosphate levels in dialysis-dependent CKD patients and introduced in the U.S. earlier this year by Fresenius Medical Care North America.

    GE Healthcare’s Vizamyl® (flutemetamol (18F) received CHMP’s recommendation for approval for visual detection of amyloid-beta neuritic plaques in the brains of patients with Alzheimer’s disease.  

    According to the EMA, the benefits of Vizamyl include its ability to help detect with high accuracy the deposition of the beta-amyloid plaques, and therefore contribute valuable additional information in diagnosing patients with Alzheimer’s. The most common side effects are flushing, increased blood pressure, headache, dizziness and nausea, the agency added.

    Teva’s Clopidogrel/Acetylsalicylic acid Teva (Clopidogrel 75 mg- ASA 75 mg, Clopidogrel 75mg- ASA 100mg) film-coated tablets intended for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA).

    Clopidogrel/Acetylsalicylic acid Teva inhibits platelet aggregation and prevents occurrence of atherothrombotic events through its ability to selectively inhibit the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex. The most common side effects are bleeding, haematoma, epistaxis, gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia, bruising, and bleeding at the puncture site, according to the EMA.

    In addition the CHMP recommended approval of new indications for six already-marketed drugs: 

    • Avastin (bevacizumab; Roche)—In combination with chemotherapy as a treatment for women with ovarian cancer that is resistant to platinum-containing chemotherapy.
    • Eliquis (apixaban; BMS and Pfizer)—Treatment of DVT (deep vein thrombosis) and PE (pulmonary embolism), and the prevention of recurrent DVT and PE, in adults.
    • Enbrel (etanercept; Pfizer)—Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).
    • Eylea (aflibercept; Regeneron Pharmaceuticals and Bayer HealthCare)—Treatment of visual impairment due to diabetic macular edema (DME).  
    • Isentress® (raltegravir; Merck Sharp & Dohme)—In combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, children, toddlers and infants from the age of 4 weeks (see sections 4.2, 4.4, 5.1 and 5.2).
    • Kalydeco™ (ivacaftor; Vertex Pharmaceuticals)—Treatment for people with cystic fibrosis (CF) ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
    • Stivarga (regorafenib; Bayer HealthCare)—Treatment of adult patients unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib

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