Emergent Therapies

New Anti-diabetic approved for European launch 

The European Medicines Authority (EMA) has granted marketing authorisation for the new once-weekly diabetes treatment albiglutide (Eperzan). Albiglutide has been licensed for two indications in type 2 diabetes:  

  • Monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance.  
  • Add-on therapy, in combination with other glucose-lowering agents, including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. 

Albiglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, administered once-weekly using an injector pen and supplied with a short (5mm) thin-wall needle. 

The European approval is based on the results of a comprehensive trial programme, comprising eight Phase 3 studies. The so-called ‘Harmony’ programme involved over 5,000 patients and evaluated albiglutide against commonly used classes of type 2 diabetes treatment, including insulin, in patients at different stages of the disease, as well as those with renal impairment. 

Albiglutide is expected to be launched in several countries in Europe in Q3-4 this year.

NHS England agrees funding for life-saving Hepatitis C drug 

NHS England has approved an £18.7 million investment in a new drug for the treatment of hepatitis C. The funding of the new oral antiviral agent, sofosbuvir (Sovaldi), could benefit around 500 patients with acute liver failure, and/or awaiting liver transplantation. 

Current estimates indicate that around 30% of people infected with chronic hepatitis C will develop cirrhosis of the liver which, in some cases, will prove fatal without a liver transplant. 

The decision, which follows recommendations from the Clinical Priorities Advisory Group (CPAG), means that while not yet NICE-approved, sofosbuvir will be funded for those patients at significant risk of mortality or who require transplantation. 

The drug, which will be available as an oral formulation, will be used in combination with another antiviral agent. 

NICE is currently developing Technology Appraisal Guidance relating to sofosbuvir, due to be published later this year. The NHS England policy position will be reviewed once NICE has published this guidance.

Promising data for abuse-deterrent pain drug

Encouraging trial results for a new treatment for severe back pain have been reported from a pivotal Phase 3 study. The drug, hydrocodone bitartrate (CEP-33237) extended-release tablets, incorporates proprietary technology providing potential abuse-deterrent properties. 

The results showed significant improvement in the treatment of patients’ chronic low back pain as measured by both weekly average Worst Pain Intensity (WPI) and weekly Average Pain Intensity (API) scores. 

Hydrocodone bitartrate is an investigational twice-daily, acetaminophen- free hydrocodone formulation in development for the management of pain severe enough to require daily, around- the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 

“There’s a significant need for an acetaminophen-free, extended-release hydrocodone formulation with potential abuse-deterrent properties,” said clinical investigator Dr Martin Hale. 

“While no technology can completely eliminate abuse, this abuse-deterrent formulation of hydrocodone is a potential positive step in the right direction.”

Regulatory Developments

RA drug approved in subcutaneous formulation

A new subcutaneous formulation of tocilizumab (RoACTEMRA) has received approval from the European Commission for the treatment of moderate to severe rheumatoid arthritis (RA) in patients who are either intolerant to or have failed to respond to other RA treatments. 

Tocilizumab is the first anti- IL-6 receptor biologic available as subcutaneous and intravenous (IV) formulations for both monotherapy and combination therapy with methotrexate (MTX). The extended label will significantly expand the number of patients who now have access to the drug. 

The approval was based on data from Phase 3 trials showing that the efficacy and tolerability of subcutaneous tocilizumab was comparable with the intravenous formulation. In addition, subcutaneous tocilizumab demonstrated long-term efficacy and significant reduced progression of joint damage over 48 weeks compared to placebo.

Clinical Studies
Zonisamide effective AS add-on in childhood epilepsy

The anti-epileptic drug zonisamide (Zonegran) is well tolerated and efficacious when used as an add-on treatment for partial epilepsy in children aged between six and 17 years, according to the results of a new study. 

The findings, from a one-year open-label extension of a randomised-controlled study of zonisamide, also showed that zonisamide was not associated with any unexpected safety issues or detrimental effects on children’s growth and development. 

Zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms of action and a novel chemical structure.

Epilepsy in children often presents major challenges such as developmental and behavioural problems, resulting in educational underachievement and a lack of self-esteem, These are frequently manifested in an attention deficit disorder, withdrawal, anxiety or depression. 

“Unfortunately, more than a fourth of children with epilepsy remain refractory to treatment,” pointed out study investigator Professor Renzo Guerrini. “There is still a need for additional treatment options. Zonisamide could be a valuable treatment option for children with partial epilepsy.” 

Zonisamide was approved in Europe in 2005 as an adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults. In July 2012, the EC approved zonisamide as monotherapy in the treatment of partial seizures in adults with newly diagnosed epilepsy. The use of the adjunctive zonisamide in the treatment of partial seizures (with or without secondary generalization) in children aged six years and above was approved by the EC in October 2013.

Ketamine shows promise for refractory depression

A UK study of the use of ketamine intravenous infusions in people with treatment-resistant depression has shown promising results. 

Carried out in an NHS clinic by researchers at Oxford Health NHS Foundation Trust and the University of Oxford, the study showed that ketamine has a rapid antidepressant effect in some patients with severe depression who have not responded to other treatments. Although many patients relapsed within a day or two, 29% had benefit which lasted at least three weeks and 15% took over two months to relapse. 

The findings also showed that ketamine did not cause cognitive or bladder side effects when given on up to six occasions, although some people did experience other side effects, such as anxiety during the infusion, nausea and vomiting. 

Ketamine is currently licensed as an anaesthetic and in pain relief. It is also
used as a recreational drug, and is to be reclassified as a Class B banned substance by the Home Office. 

The Oxford team have now given over 400 infusions to 45 patients and are exploring ways to maintain the effect. Results from their study, funded by National Institute for Health Research (NIHR) Research for Patient Benefit Program, are published in the Journal of Psychopharmacology.