September's top stories: Takeda gets EU approval for type 2 diabetes therapies

Takeda has received marketing authorisation from the European Commission for its three new type 2 diabetes therapies - Vipidia, Vipdomet and Incresync - while Dendreon has received European approval to market its prostate cancer therapy Provenge. Drugdevelopment-technology.com wraps up the key headlines from September 2013.


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Takeda secures European approval for three type 2 diabetes therapies

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Japan-based Takeda Pharmaceutical Company has received marketing authorisation (MA) from the European Commission (EC) for its three new type 2 diabetes therapies Vipidia (alogliptin), Vipdomet (alogliptin with metformin) and Incresync (alogliptin with pioglitazone).

Vipidia has been designed to treat type 2 diabetes in adults aged 18 years and older to improve glycaemic control in combination with other glucose reducing medicinal products including insulin.

Vipdomet and Incresync will be used for the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus.

Zalicus gets FDA orphan drug status for pain drug

The US Food & Drug Administration (FDA) Office of Orphan Product Development has granted orphan drug designation for Zalicus's Z160, used for the treatment of pain resulting from shingles.

Biopharmaceutical firm Zalicus said Z160 is an oral, state-dependent, selective N-type calcium channel (Cav 2.2) modulator for postherpetic neuralgia (PHN), a painful neuropathic condition resulting from an outbreak of the herpes zoster virus, also known as shingles.

The orphan designation is reserved for compounds intended at treating conditions, which impact fewer than 200,000 people in the US and provides tax credits for clinical research costs.

Dendreon gets EU marketing authorisation for prostate cancer vaccine

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US-based biotechnology company Dendreon (DNDN) has received European Commission (EC) approval to market its prostate cancer therapy Provenge (sipuleucel-T) in the European Union (EU).

Provenge, which is a therapeutic cancer vaccine for prostate cancer (CaP), is intended for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.

The European Medicines Agency (EMA) Committee for Advanced Therapy (CAT) and the Committee for Medicinal Products for Human Use (CHMP) have recently provided positive opinions for marketing Provenge in the EU.

Conatus begins dosing in trial of emricasan for alcoholic hepatitis patients

Biotechnology firm Conatus Pharmaceuticals (CNAT) has started dosing in the Phase II clinical trial of emricasan, an orally active caspase protease inhibitor, in patients with severe alcoholic hepatitis.

The Translational Research and Evolving Alcoholic Hepatitis Treatment (TREAT) consortium comprising Mayo Clinic Rochester, Indiana University and Virginia Commonwealth University, in collaboration with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is carrying out the trial.

The placebo-controlled, multicentre and double-blind trial is intended to assess if emricasan can improve the 28-day survival in patients with chronic liver disease caused by alcohol and contraindicated to receive corticosteroid therapy for their alcoholic hepatitis.

Creabilis initiates treatment in Phase IIb study of dermatitis drug

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Creabilis, a clinical stage European biotechnology firm, has treated the first patients in its Phase IIb study of its lead product, CT327 (a TrkA kinase inhibitor), for patients with atopic dermatitis (AD).

The Phase IIb trial of CT327 is a multicentre, randomised, double-blind, placebo-controlled study carried out on adult and adolescent patients older than 12 years with mild to moderate AD and at least moderate pruritus.

According to the company, the primary endpoints of the trial will analyse pruritus using a visual analogue scale (VAS), control of disease determined by Investigator Global Assessment (IGA) and also quality of life measures.

OncoMed starts Phase Ib/II study of anti-cancer stem cell drug

OncoMed Pharmaceuticals has initiated a Phase Ib/II ovarian cancer trial of its anti-cancer stem cell product candidate, demcizumab (OMP-21M18), a humanised monoclonal antibody that inhibits Delta-Like Ligand 4 (DLL4) in the Notch signalling pathway.

The study, which is being partly funded under an ovarian cancer National Cancer Institute SPORE Grant Programme, will enrol patients at the MD Anderson Cancer Center in Houston, Texas, US.

During the Phase Ib/II trial, demcizumab will be tested in combination with paclitaxel in patients with platinum-resistant ovarian cancer, fallopian tube cancer or primary peritoneal cancer.

Takeda's ulcerative colitis treatment gets US FDA priority review status

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Takeda Pharmaceuticals USA, a subsidiary of Japan-based Takeda Pharmaceutical Company, has secured priority review status from the US Food and Drug Administration (FDA) for the biologics license application (BLA) for its new investigational drug vedolizumab.

Vedolizumab, which is under development for the treatment of Crohn's disease (CD) and ulcerative colitis (UC), is a humanised monoclonal antibody that specifically antagonises the alpha4beta7 (a4ß7) integrin, inhibiting the binding of a4ß7 to intestinal mucosal addressin cell adhesion molecule one (MAdCAM-1).

The new drug will be used for the treatment of adults with moderately to severely active CD and UC, which are the two most common forms of inflammatory bowel disease (IBD).

Daiichi Sankyo's Phase III Hokusai-VTE study meets primary efficacy endpoint

Daiichi Sankyo has released results of the global Phase III Hokusai-VTE study that evaluated the investigational, oral, once-daily anticoagulant direct factor Xa-inhibitor edoxaban in patients with acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), or both.

Factor Xa is a vital factor in the coagulation system that leads to blood clotting.

The study, which enrolled 8,292 patients in 439 clinical sites across 37 countries, found that edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin, after using heparin in both arms to treat and prevent recurrent symptomatic venous thromboembolism (VTE).

GSK's melanoma drug receives European approval

UK-based pharmaceutical firm GlaxoSmithKline (GSK) has received approval from the European Commission (EC) for the marketing of its Tafinlar (dabrafenib) as an oral targeted treatment.

The EU authorisation for dabrafenib was based on positive results from several multicentre global trials.

Data from BREAK-3, a Phase III study comparing dabrafenib to dacarbazine (chemotherapy) in 250 previously untreated patients with BRAF V600E mutation-positive unresectable or metastatic melanoma, showed a median progression-free survival of 5.1 months with dabrafenib (95% CI; 4.9, 6.9) compared to 2.7 months for dacarbazine (95% CI: 1.5, 3.2) (2011 cut-off data).

FDA accepts Neurovance's IND application for ADHD drug

The US Food and Drug Administration (FDA) has accepted Neurovance's investigational new drug (IND) application for EB-1020 SR, a norepinephrine and dopamine-preferring triple reuptake inhibitor.

EB-1020 SR is being developed to treat all subtypes of adult attention deficit hyperactivity disorder (ADHD) with reduced risk of addiction, abuse and diversion.

Neurovance has also started a Phase IIa study in adult patients with ADHD and results from this trial are anticipated to be revealed in early 2014.