Instant Report
FDF

Date: 25-Sep-2019

EMA committee recommends marketing approval for AstraZeneca's Qtrilmet to treat type-2 diabetes

AstraZeneca, a global, science-led biopharmaceutical company, announced that Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets have been recommended for marketing authorisation in the European Union for the treatment of adults with type-2 diabetes (T2D). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on data from five phase III trials which evaluated combinations of Forxiga (dapagliflozin) and Onglyza (saxagliptin) on a background of metformin in patients with inadequately-controlled T2D. The primary endpoint in these trials was mean change from baseline in HbA1c (average blood glucose levels) at week 24 or 52 Across the trials, the combination of Forxiga, Onglyza and metformin was superior in reducing HbA1c versus Forxiga combined with metformin, Onglyza combined with metformin, or glimepiride combined with metformin. The combination of Forxiga, Onglyza and metformin with or without sulphonylurea (SU) was non-inferior to the combined use of insulin and metformin with or without SU in reducing HbA1c.

Date: 20-Oct-2020

EMA Committee Recommends Marketing Approval For AstraZenecas Trixeo Aerosphere For Maintenance Treatment Of COPD

AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been recommended for marketing authorisation in the European Union (EU) for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA), or a combination of a LABA and a long-acting muscarinic antagonist.

Trixeo Aerosphere, a triple-combination therapy, is approved under the brand name Breztri Aerosphere in Japan, China and the US for patients with COPD.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the ETHOS phase III trial in which Trixeo Aerosphere showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate) over 52 weeks.

The recommendation for approval was also supported by data from the KRONOS phase III trial. In both trials, the safety and tolerability of Trixeo Aerosphere were consistent with the profiles of the dual comparators.

Klaus Rabe, Professor of Pulmonary Medicine at the University of Kiel, Director of the Department of Pneumology at Clinic Grosshansdorf, Germany, Lead Investigator of the ETHOS trial and National Co-ordinating Investigator of the KRONOS phase III trial said, “Preventing exacerbations is central to the management of chronic obstructive pulmonary disease, as exacerbations may cause irreversible damage and disease progression. The triple-combination therapy, Trixeo Aerosphere, has demonstrated significant benefits in reducing moderate or severe exacerbations in patients suffering from this debilitating disease.”

Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said, “Chronic obstructive pulmonary disease is now the third leading cause of death globally and affects approximately one in 10 adults over the age of 40 in Europe. Trixeo Aerosphere has demonstrated strong clinical benefit when compared with dual-combination therapies and this positive recommendation brings us closer to providing a much-needed new treatment to patients in Europe.”

COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 38 million people and is the third leading cause of death globally. In Europe, approximately 10% of adults over the age of 40 have COPD. Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important treatment goals in the management of COPD. A single COPD exacerbation can have a negative impact on lung function, quality of life and increase the risk of hospitalisation. Additionally, even one COPD exacerbation that results in hospitalisation increases the risk of death.

The ETHOS and KRONOS phase III trials are part of AstraZeneca’s ATHENA phase III clinical trial programme for Trixeo Aerosphere, which included more than 15,500 patients globally across 11 trials.

ETHOS is a randomised, double-blinded, multi-centre, parallel-group, 52-week phase III trial to assess the efficacy and safety of Trixeo Aerosphere in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year. The primary endpoint was the rate of moderate or severe exacerbations.

KRONOS is a randomised, double-blinded, parallel-group, 24-week, chronic-dosing, multi-centre Phase III trial to assess the efficacy and safety of Trixeo Aerosphere in patients with moderate to very severe COPD regardless of whether or not they had an exacerbation in the previous year.

Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) is a single-inhaler, fixed dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a LAMA, with budesonide, an ICS, and delivered in a pressurised metered-dose inhaler. Trixeo Aerosphere is approved under the brand name Breztri Aerosphere in Japan, China and the US for patients with COPD

Date: 02-Feb-2021

EMA Committee Recommends Marketing Approval For Novo Nordisks Once-weekly Sogroya To Treat AGHD

AstraZeneca announced that it will work with The Ethiopian Federal Ministry of Health and The Ethiopian Thoracic Society, as part of their new Africa PUMUA Initiative, aimed at redefining asthma care in Africa.

The Africa PUMUA Initiative looks at addressing the barriers currently preventing access to care for patients with asthma

The Initiative was designed in consultation and collaboration with government, healthcare societies and respiratory health experts to strengthen local health systems and centres to improve paediatric and adult asthma management across both the public and private sectors.  The Africa PUMUA Initiative will support fundamental changes needed to advance clinical practice aligned to the Non Communicable Disease (NCD) service decentralisation programme roll-out by the Ethiopian Federal Ministry of Health.  

Globally, more than 339 million people are living with asthma, with an estimated over 40 million people with asthma in Africa .The World Health Organisation (WHO) cautions that over 80% of asthma-related deaths occur in low-and lower-middle income countries.

AstraZeneca has launched the Africa PUMUA Initiative to highlight its commitment to improving the health outcomes of patients in Africa. By providing support of infrastructure, increasing awareness of the symptoms and risks of asthma, and building the capacity of all role players across the patient journey, the Africa PUMUA Initiative looks at addressing the barriers currently preventing access to care for patients with asthma.

As part of the partnership signed on 27 January 2021, with The Ethiopian Federal Ministry of Health and The Ethiopian Thoracic Society, AstraZeneca will provide 150 nebuliser machines to various hospitals within Ethiopia, as well as establish 47 nebulisation stations. The nebulisers will be allocated in consultation with the Ministry of Health and the Ethiopian Thoracic Society.

Barbara Nel, AstraZeneca country president for African Cluster said: “We are unwavering in our commitment to improve care for asthma patients across Africa.  People living with asthma should have the ability to live normal lives and deserve the best care. Through our Africa PUMUA initiative we aim to strengthen local health systems and centres. By working together to boost local medical knowledge and expertise and building an infrastructure for Asthma Patients, through the donation of nebulisation machines, nebulisation stations, spirometers and peak flow meters, we believe we will be able to redefine asthma care in Ethiopia.”

Dr Dereje Duguma , Ethiopian Federal Ministry of Health, said: Through this important Public-Private Partnerships with the AstraZeneca Pharmaceutical and the Ethiopian Thoracic Society we will bring immense transformation to Asthma care. The partnership also goes in line with the Government of Ethiopia’s National Strategic Action Plan for Non-Communicable Diseases, effective diagnosis and enhanced referral systems. PUMUA will be a great tool in decentralization of these efforts. We hope this will be a good start to collaborating with AstraZeneca and look forward to seeing more endeavours. MOH supports pharmaceutical companies investing in the country as it is one of the key strategic areas in developing industries in the country.”

“It is estimated that more than 5 million people in Ethiopia are living with asthma, and to date there has been no national treatment guidelines for the diagnosis and treatment of Asthma. The Ethiopian Thoracic Society strongly believes that the implementation of the Africa PUMUA initiative will contribute significantly to the effective diagnosis and management of asthma. The capacity building activities and the update and alignment of treatment guidelines and protocols for chronic asthma to GINA (Global Initiative for Asthma management) guidelines, will help to improve outcomes for asthma patients in Ethiopia. Cascading the treatment protocol and guidelines throughout the country will enable us provide standardised asthma diagnosis and treatment in Ethiopia,” said Ethiopian Thoracic Society President, Dr Tewodros Haile Gebremariam

The initiative will launch initially across 6 countries in Africa, including Ethiopia, Ghana, Kenya, Ivory Coast, Cameroon and Senegal, and then expand to other countries.

Date: 02-Mar-2021

EMA Committee Recommends Marketing Approval For Biocon Biologics & Viatris Biosimilar Bevacizumab

Biocon Biologics has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of their biosimilar bevacizumab, co-developed with Viatris, to be marketed as Abevmy (injection bevacizumab 100mg and 400mg).


Abevmy is a biosimilar to Roche’s Avastin, prescribed for all indications including metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of a specific regimen.

The decision of the European Commission (EC) is expected in May 2021, which, when approved, will grant marketing authorization in the 27 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. For the UK, the Medicines and Healthcare Products Regulatory Agency’s ‘reliance procedure’ will be followed, and the UK marketing authorization can be expected shortly after the EC decision.

Kiran Mazumdar-Shaw, executive chairperson, Biocon Biologics, said: “CHMP's decision to recommend approval of our biosimilar bevacizumab brings us a step closer to enable affordable access to this biologic therapy for cancer patients in the EU along with our partner Viatris. It is an outcome of our commitment to expand access for patients leveraging our science and global scale manufacturing for a range of biosimilars. Through bTrastuzumab and bPegfilgrastim we are already making a difference to the lives of cancer patients in several EU countries. We look forward to a final decision from the European Commission approving biosimilar bevacizumab, which will add to our efforts in cancer care.”

Abevmy, bBevacizumab, is a recombinant “humanized” monoclonal antibody that selectively binds to human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity. Bevacizumab inhibits the formation of tumor vasculature, thereby inhibiting tumor growth.