Pharmaceutical Market Europe • February 2024 • 8-9
NEWS
Roche’s Tecentriq approved by
EC for multiple cancer types
Roche has announced that an injectable form of its PD-L1 inhibitor Tecentriq (atezolizumab) has been approved by the European Commission (EC) for multiple cancer types.
The subcutaneous (SC) formulation of Tecentriq, which combines Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology, reduces treatment time by approximately 80%, with most injections taking between four to eight minutes compared with 30 to 60 minutes for an intravenous (IV) infusion.
The EC’s marketing authorisation makes Tecentriq SC the first injectable PD-L1 cancer immunotherapy in the EU and applies to all indications in which the drug’s IV form has. previously been approved, including certain types of lung, liver, bladder and breast cancer.
The regulator’s decision was supported by results from the phase 1b/3 IMscin001 study, which demonstrated comparable levels of Tecentriq in the blood when administered subcutaneously, as well as a safety and efficacy profile consistent with the IV formulation.
Additionally, 90% of healthcare professionals (HCPs) surveyed as part of the study agreed that the SC formulation is easy to administer and 75% noted that it could save time for healthcare teams.
Alongside offering shorter treatment time, Tecentriq SC may be administered by HCPs outside of hospitals, in community care settings, or at patients’ homes, depending on national regulations and health systems.
FDA authorises Florida to import cheaper prescription drugs from Canada
The US Food and Drug Administration (FDA) has authorised Florida’s first-of-its-kind request to directly import cheaper prescription drugs from Canada.
Prescription drug pricing has been an ongoing issue in the US, which is reportedly spending more than double the average amount spent by other OECD member countries on prescription medicines per capita.
Florida’s Canadian Prescription Drug Importation Program, which will initially focus on a small number of drug classes to treat conditions such as diabetes and prostate cancer, is expected to save the state up to $180m in its first year.
The plan will be authorised for two years from the date the FDA is notified of the first shipment of drugs to be imported, the regulator said.
Before drugs can be imported, however, the state’s Agency for Health Care Administration (AHCA) must comply with a series of obligations related to the programme.
This includes relabelling the drugs to be consistent with that approved by the regulator, and ensuring that the drugs have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards.
The AHCA must also submit a quarterly report to the FDA that includes information about the imported drugs, cost savings and any potential safety and quality issues.
EC opens participation
to new drug shortage alliance
The European Commission’s (EC) Health Emergency Preparedness and Response Authority has launched an open call for expression of interest to join a new alliance aimed at preventing and addressing critical medicine shortages over the next five years.
First announced in October 2023, the Critical Medicines Alliance will bring together relevant stakeholders to develop recommendations and provide advice to the EC, member states and other EU decision makers on how to address long-standing medicine shortages.
The EU has been facing ongoing shortages, including of certain antibiotics, underpinning a need to make its medicine supply chains more resilient.
Building on the Union list of critical medicines published by the European Medicines Agency in December, the alliance will focus on medicines with the highest risk of shortages and the highest impact on healthcare systems and patients.
It will build on the experience from other EU alliances that address major industrial challenges and will be able to rely on a “varied toolbox” of policy measures, the EC said.
This includes exploring how to diversify global supply chains through strategic international partnerships, developing a common strategic approach to medicines stockpiling in the EU, and helping to leverage and align EU and national funding to implement solutions to the shortages.
UK national study supports whole genome sequencing in standard cancer care
A new landmark UK study has shown that combining whole-genome sequencing (WGS) and real-world clinical data at a national scale can help deliver personalised cancer therapy.
Published in Nature Medicine, the largest-of-its-kind national trial combined data from the UK’s 100,000 Genomes Project and NHS records to further understand cancer and help researchers develop new treatments.
Researchers from Genomics England, NHS England, Queen Mary University of London, Guy’s and St Thomas’ NHS Foundation Trust and the University of Westminster analysed the data of over 30 kinds of solid tumours, collected from over 13,000 patients with cancer over five years.
The findings showed that WGS provided a comprehensive view of a tumour’s genetic landscape by detecting various genetic changes in a single test.
Across different cancer types, researchers found that more than 90% of brain tumours and over 50% of colon and lung cancers showed genetic changes, which could affect how patients are treated and guided on decisions relating to surgery or specific
treatments.
Furthermore, over 10% of sarcomas had larger DNA changes, otherwise known as structural variants, which could impact clinical care and treatment, and more than 10% of ovarian cancers had inherited risks, which offered crucial insights for clinical care.
Michael J Fox Foundation awards Vesper Bio over $870,000 for Parkinson’s treatment
The Michael J Fox Foundation (MJFF) for Parkinson’s disease (PD) has awarded Vesper Bio a grant totalling $873,000 to assess sortilin inhibitors in the treatment of PD.
Beginning in January 2024, the project received the award under the MJFF’s PD Therapeutics Pipeline Program to advance preclinical testing of therapeutic developments to address unmet medical needs of the neurological condition.
Vesper is currently expediting the development of VES001 for GRN-related frontotemporal dementia through ongoing phase 1 studies.
Progranulin is a protein that the body uses to regulate cell growth, survival, repair and avoid inflammation. When levels of the protein are low, cell dysfunction can occur and cause a range of neurological damage.
Vesper’s VES001, a brain-penetrant treatment that is given orally, works by targeting the progranulin deficiency and is able to cross the blood-brain barrier.
The clinical-stage biotech company suggests that its compounds will have a disease-modifying effect when normalising progranulin levels to protect and preserve remaining cells.
The studies will include a phase 1b proof of concept in GRN mutation carriers ahead of potentially registrational phase 2/3 trials, as well as a phase 1 readiness of VES002, a treatment focused on a second central nervous system indication.
Novo Nordisk’s once-weekly IcoSema shows promise in phase 3a type 2 diabetes trial
Novo Nordisk has shared positive top-line results from a phase 3a trial of once-weekly IcoSema in type 2 diabetes patients inadequately controlled by daily basal insulin.
The COMBINE 3 study has been comparing a weekly injection of IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide, to daily injections of insulin glargine U100 combined with insulin aspart, dosed with or without oral glucose-lowering medications.
The trial met its primary endpoint, demonstrating non-inferiority in reducing blood glucose levels at week 52 with once-weekly IcoSema compared with daily insulin glargine and insulin aspart.
From an overall baseline HbA1c of 8.30%, once-weekly IcoSema achieved an estimated reduction in HbA1c of 1.47 percentage points compared with 1.40 percentage points for daily insulin glargine and insulin aspart.
Patients receiving once-weekly IcoSema also achieved a superior reduction in the estimated change in body weight as well as lower rates of hypoglycaemia.
More than 4.9 million people in the UK have diabetes, around 90% of which have type 2 diabetes, according to Diabetes UK.
It is hoped that the introduction of a weekly treatment option could lead to improved adherence rates and an overall higher quality of life for patients.