October 2020 • PharmaTimes Magazine • 8-9
// MEDICINE //
Novo Nordisk has launched in the UK the first 'protein in a pill' treatment for type 2 diabetes.
Rybelsus (semaglutide tablets) is the world’s first and only oral GLP-1 receptor agonist (RA), which physicians in the UK, including GPs, can now prescribe for adults with insufficiently controlled type 2 diabetes to improve glycaemic control.
In the PIONEER clinical development programme, Rybelsus showed significantly greater HbA1c reduction at one year, with the additional benefit of consistent weight reduction, versus treatments used in the UK: sitagliptin, empagliflozin and liraglutide.
It is hoped that the availability of an oral GLP-1 RA – which, as protein-based treatments, were until now only deliverable by injection – might improve patient adherence to this class of medicines. Also, Rybelsus prescriptions can be initiated remotely, which is a particular advantage during the pandemic given that diabetes increases the risk of death from coronavirus, Novo highlighted.
“GLP-1 RAs are recognised as offering glycaemic control and weight loss benefits compared to other types of type 2 diabetes treatment, but are clinically underutilised because they are only available as injectables,” said Professor Steve Bain, Professor of Medicine (Diabetes) at Swansea University Medical School. “Being able to offer patients the option of a GLP-1 RA in a pill may make it easier for physicians, including GPs, to intensify treatment earlier for people with type 2 diabetes who are not controlled on their current treatment, helping them achieve their clinical treatment goals and reduce their risk of serious complications.”
The Danish drugmaker confirmed that oral semaglutide is priced “at parity with other GLP-1 RAs in the UK”, and it noted that the cost-effectiveness of GLP-1 RAs has already been determined in national guidelines including The National Institute for Health and Care Excellence (NICE) and the Scottish Medicine Consortium (SMC).
As such, NICE will not be carrying out a single technology appraisal (STA) for oral semaglutide, and so Novo said it will work with the NHS to ensure that physicians, including GPs, in England and Wales can secure access for their patients.
Roll out for Shionogi's novel antibiotic
Meanwhile, Shionogi has launched in the UK its new antibiotic Fetcroja (cefiderocol), which targets infections caused by aerobic Gram-negative bacteria.
Data from a range of multinational surveillance studies has shown that Fetcroja can produce potent in vitro activity against a broad spectrum of aerobic Gram-negative pathogens, including all three pathogens identified by the World Health Organization as being of a ‘critical priority’.
Antimicrobial resistance (AMR) is fast becoming a critical health issue across the globe, causing an increased need for new antibiotics to address the burden. In the EU, around 25,000 deaths per year are caused by an infection with multidrug-resistant bacteria, while in the UK over 5,000 deaths can be attributed to AMR.
According to experts, if no action is taken antibiotic resistance is predicated to kill ten million people every year globally by 2050, with a total cost to global economic output of $100 trillion, highlighting the urgent need to grow the arsenal of effective antibiotics.
Merck and Pfizer’s Bavencio (avelumab) is now available under the UK's Early Access to Medicines Scheme (EAMS), giving some patients with bladder cancer the chance to receive treatment with the immunotherapy before its approval in Europe.
The positive scientific opinion issued by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) allows patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy to get first-line maintenance treatment with the drug.
The decision rides on data from the Phase III JAVELIN Bladder 100 study, which showed a significant 7.1-month improvement in median overall survival (OS) with Bavencio as first-line maintenance plus best supportive care (BSC) compared with BSC alone: 21.4 months versus 14.3 months. This represents a 31% reduction in the risk of death in the overall population.
Platinum-based chemotherapy is currently the first-line standard of care for eligible patients with advanced disease based on high initial response rates, but most patients will ultimately experience disease progression within nine months of initiation of treatment and only 5% of patients with metastatic disease will live longer than five years, highlighting the need for improved treatment options.
“Avelumab is the first immunotherapy to demonstrate in a clinical trial a statistically significant improvement in overall survival as a first-line treatment for patients with advanced urothelial carcinoma,” noted Dr Olivia Ashman, Oncology medical director, Pfizer UK. “It is our greatest hope that our maintenance approach can eventually become part of routine clinical practice and significantly prolong survival for these patients.”
Health experts are calling for a change in the law that would give pharmacists the power to alter prescriptions.
A joint letter co-signed by the Royal Pharmaceutical Society, the British Medical Association, the Royal College of GPs, patient group National Voices and others, argues that the move will reduce the impact of medicine shortages on patient care.
Currently, community pharmacists are not able to amend original prescriptions for even minor adjustments, and are legally obliged to contact prescribers or refer patients back to prescribers instead.
This means that patients can experience delays in access to medicines if the specified quantity, strength or formulation of a medicine is in short supply, with pharmacists being unable to offer a different version of the same medicine as an alternative.
“We urgently need this change ahead of the triple whammy of a second wave of coronavirus, the flu season and a potential no-deal Brexit, all of which would again place heavy demands on the medicines supply chain and primary care services,” said Sandra Gidley, President of the RPS. “Pharmacists are experts in medicines and need greater flexibility under the law to make simple changes to prescriptions that help patients get the medicines they need when they need them”.