Pharmaceutical Market Europe • February 2023 • 8-9
NEWS
AstraZeneca’s severe asthma treatment approved in EU for self-administration
AstraZeneca’s Tezspire (tezepelumab) has been approved for self-administration in patients with severe asthma aged 12 years and older after it received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).
The CHMP’s opinion, which can be implemented without the need for a European Commission decision due to the nature of the type-2 label variation, makes AZ’s pre-filled pen the first and only severe asthma biologic approved in the EU with no phenotype or biomarker limitations.
The approval was based on results from the PATHFINDER clinical trial programme, which included results from the PATH-BRIDGE phase 1 trial and the PATH-HOME phase 3 trial.
Throughout the PATH-HOME trial, 92% of healthcare providers, patients and caregivers were able to successfully administer Tezspire both in the clinic and at home.
Also included in the PATHFINDER clinical trial programme was the pivotal NAVIGATOR phase 3 trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma when added to standard therapy.
Tezspire is being developed by AZ in collaboration with Amgen as a first-in-class human monoclonal antibody and has been approved in the EU, US and other countries for the treatment of severe asthma.
Biogen and Eisai’s Alzheimer’s drug receives FDA accelerated approval
Biogen and Eisai’s Leqembi (lecanemab-irmb) has been approved by the US Food and Drug Administration (FDA) under the accelerated approval pathway to treat Alzheimer’s disease.
Specifically, Leqembi is indicated for patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
The FDA’s decision was based on phase 2 data showing that Leqembi reduced the accumulation of amyloid beta plaque in the brain, a defining feature of Alzheimer’s disease.
Eisai has also submitted a supplemental biologics application (sBLA) to the FDA for approval under the traditional pathway, the companies said.
The sBLA is based on data from the phase 3 confirmatory Clarity AD clinical trial. The study met its primary endpoint and reduced clinical decline by 27% on the global cognitive and functional scale – Clinical Dementia Rating-Sum of Boxes – compared with placebo at 18 months.
All key secondary endpoints also showed highly statistically significant results compared with placebo, the companies reported, including other measures of cognition and daily function.
The Japanese company said it also planned to apply for marketing authorisation for Leqembi in Japan and the EU by the end of its business year on 31 March.
AbbVie and Eli Lilly leave UK’s voluntary drug pricing agreement
AbbVie and Eli Lilly have withdrawn from the UK’s Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), according to an update by the Association of the British Pharmaceutical Industry (ABPI).
The companies will now come under the alternative statutory scheme imposed by the government through law, highlighting what the ABPI describes as ‘the depth of feeling that the current voluntary scheme is damaging the UK life sciences industry’.
Introduced in 2019, the VPAS scheme caps the growth of NHS branded medicine spending at a nominal rate of 2% per year, with the industry returning any spending beyond the cap in the form of a levy.
However, companies are arguing that it is no longer possible to justify the voluntary scheme to global boardrooms and investors.
In December, the government announced that those within the voluntary scheme would be required to return almost £3.3bn in sales revenue – 26.5% of sales – up from around £0.6bn in 2021 and £1.8bn in 2022.
The ABPI warned that if the UK is unable to address rapidly escalating rates in future years and repayment rates return to ‘historical norms’, it would increasingly see investment, jobs and research partnerships going to more supportive markets in the US, Europe and Asia.
NICE recommends wider use of statins to cut risk of heart attack and stroke
The National Institute for Health and Care Excellence (NICE) has published new guidance on the use of daily cholesterol-lowering statin pills, advising that they can now be considered for more people to reduce their risk of having a heart attack or stroke.
Up until now, NICE has recommended that those with a 10% or higher risk over ten years of a cardiovascular event should be offered a statin – guidance that remains unchanged.
Now, it is also recommending that statins can be considered as part of shared decision-making for those who have not had a cardiovascular disease (CVD) event with a ten-year CVD risk score of less than 10%.
The change comes after the independent committee updating the NICE guideline on CVD risk assessment and reduction considered new evidence on the side effects and safety of statins.
NICE estimates that under the new recommendation, for every 1,000 people with a 5% risk of a CVD event over the next ten years who take statins, about 20 people will not get heart disease or have a stroke.
This figure doubles to 40 for people with a risk of 10%, and to around 70 for those with a risk of 20%.
California sues largest US insulin manufacturers and PBMs for overpricing
The state of California in the US is suing the nation’s largest insulin manufacturers and pharmacy benefit managers (PBMs) for allegedly using their market power to overcharge patients for the life-saving drug, the state’s attorney general Rob Bonta announced.
Eli Lilly, Novo Nordisk and Sanofi produce over 90% of the global insulin supply and the PBMs CVS Caremark, Express Scripts and OptumRx administer pharmacy benefits for around 80% of prescription claims managed.
The lawsuit argues that because competition is highly limited in both their markets, these six companies are able to keep ‘aggressively hiking’ the list price of insulin at the expense of patients, violating the state’s Unfair Competition Law.
According to a 2021 Congressional report, Eli Lilly, Novo Nordisk and Sanofi have raised the price of their insulin by 1,219%, 627% and 715%, respectively, since they were first launched.
The California Health and Human Services Agency reported this year that, according to national data, as many as one in four diabetics cannot afford their insulin, forcing them to ration or stop taking insulin altogether.
Other states including Minnesota, Mississippi, Arkansas and Kansas, as well as groups of drug purchasers, have previously brought legal action over insulin pricing.
Novo Nordisk’s type 2 diabetes drug approved by FDA as first-line option
Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved a label update for Rybelsus (oral semaglutide), which is now indicated as a first-line treatment option for adults with type 2 diabetes.
The update removes a previous limitation of use that stated that the drug should not be used as the initial therapy.
Initially approved in the US in 2019, Rybelsus is the first and only analogue of the naturally occurring hormone glucagon-like peptide-1 in pill form and is indicated, along with diet and exercise, to improve glycaemic control for adult patients with type 2 diabetes.
Rybelsus works differently from other diabetes pills to lower blood sugar by increasing the release of insulin from the pancreas when blood sugar is high, decreasing the release of sugar from the liver, and slowing the process of food leaving the stomach after eating.
The FDA’s 2019 decision on Rybelsus was based on the results from ten PIONEER clinical trials, which included 9,543 adults with type 2 diabetes.
In the programme, Rybelsus was shown to more effectively lower blood sugar than sitagliptin and empagliflozin, and treatment with Rybelsus also resulted in up to 4.4kg reduction in body weight.