FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine - Arexvy from GSK

On 3 May 2023, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States.

Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.

RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups.

RSV circulation is seasonal, typically starting during the fall and peaking in the winter.

In older adults, RSV is a common cause of lower respiratory tract disease (LRTD), which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs).

According to the U.S.Centers for Disease Control and Prevention, each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older.

The safety and effectiveness of Arexvy is based on the FDA’s analysis of data from an ongoing, randomized, placebo-controlled clinical study conducted in the U.S. and internationally in individuals 60 years of age and older.

The main clinical study of Arexvy was designed to assess the safety and effectiveness of a single dose administered to individuals 60 years of age and older.

Participants will remain in the study through three RSV seasons to assess the duration of effectiveness and the safety and effectiveness of repeat vaccination.

Data for a single dose of Arexvy from the first RSV season of the study were available for the FDA’s analysis.

In this study, approximately 12,500 participants have received Arexvy and 12,500 participants have received a placebo.

Among the participants who have received Arexvy and the participants who have received a placebo, the vaccine significantly reduced the risk of developing RSV-associated LRTD by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%.

Among a subset of these clinical trial participants, the most commonly reported side effects by individuals who received Arexvy were injection site pain, fatigue, muscle pain, headache and joint stiffness/pain.

Among all clinical trial participants, atrial fibrillation within 30 days of vaccination was reported in 10 participants who received Arexvy and 4 participants who received placebo.

The FDA is requiring the company to conduct a postmarketing study to assess the signals of serious risks for Guillain-Barré syndrome and ADEM.

In addition, although not an FDA requirement, the company has committed to assess atrial fibrillation in the postmarketing study

 

New drug approved by US FDA for the treatment of COPD

The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. 

COPD is a serious lung disease that worsens over time. Symptoms can include chest tightness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute, and COPD is the third leading cause of death in the United States.

Breo Ellipta works by decreasing inflammation in the lungs and helping the muscles around the airways of the lungs stay relaxed to increase airflow and reduce exacerbations in patients with COPD.

“COPD is a serious disease that makes breathing difficult,” said Curtis Rosebraugh, M.D., M.P.H., director, Office of Drug Evaluation II, Center for Drug Evaluation and Research, FDA. “The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD.”

Breo Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA). The safety and efficacy of Breo Ellipta were evaluated in 7,700 patients with a clinical diagnosis of COPD. Those treated showed improved lung function and reduced exacerbations compared to placebo.

The drug carries a boxed warning that LABAs increase the risk of asthma-related death. The safety and efficacy of Breo Ellipta in patients with asthma have not been established, and it is not approved for the treatment of asthma.

The FDA approved Breo Ellipta with a patient medication guide that includes instructions for use and information about the potential risks of taking the drug. Breo Ellipta should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm) and is not recommended for people younger than 18 years.

Breo Ellipta may cause serious side effects, including increased risks of pneumonia and bone fractures. The most common side effects reported by patients using Breo Ellipta included inflammation of the nasal passage (nasopharyngitis), upper respiratory tract infection, headache, and oral candidiasis (thrush).

Breo Ellipta was developed by GlaxoSmithKline, Research Triangle Park, N.C., in collaboration with San Francisco-based Theravance.

Source: FDA

GSK signals a new journey with Electroceuticals

Pharmaceuticals, Nutraceuticals and now Electroceuticals!!

 

Glaxosmithkline (NYSE:GSK) have announced their entry into a new field of medicine known as Electroceuticals. The company have entered into academic institutions and encourage research on developing new therapeutics which can treat diseases via electrical signals. The company is crowdsourcing for this venture has announced a prize money of $1 million for an innovative treatment option.

The company is nterested in projects that begin detailing how nerves in the body are related to particular diseases, understand the firing patterns of those nerves, and explore new technologies that will enable to interface with multiple individual nerve fibres.  As a first step, the company has put up an Ideation challenge via Innocentive with a prize money of $ 5000

Details of the Ideation Challenge:

Bioelectronic medicines or “electroceuticals” promise to treat disease by modulating neural electrical impulses. Which specific disease has a major peripheral neural control component and would be the best proof of principle for such medicines?

You do not need to perform any experiments, only to describe the conceptual approach and need in a total of 3 pages!

This is an Ideation Challenge with a guaranteed award for at least one submitted solution. Solvers can also be considered for research funding.

GlaxoSmithKline (GSK) will also be convening an international conference for the bioelectronic research community in December 2013, encouraging researchers to meet, build relationships and share early findings.

A commentary on Nature is quite fascinating read and I’m certainly interested to know more about and I have more to post on this subject in the near future… Watch out for more….

Access to Medicine Index 2012

The Access to Medicine Index is an independent initiative that ranks the world’s 20 largest companies according to their efforts to improve access to medicine in developing countries, highlighting policy and practice that either facilitate or hinder access. It is published every two years by the Access to Medicine Foundation, which aims to encourage pharmaceutical companies to make their products more available, affordable and accessible for the millions of people worldwide who do not have reliable access to medicine

The Index uses a framework that evaluates company activities in seven areas of activity considered to be
key to enhancing access to medicine in developing countries. It analyses 101 indicators across these
areas, and within each, the indicators are distributed across four types of action to assess the level
of commitment the company demonstrates, how transparent it is about what it is doing, what specific
activities it is engaged in and how innovative its approach is.


The Index covers 20 companies, 103 countries, and a broad range of products such as drugs, vaccines,
diagnostic tests and other health-related technologies necessary for preventing, diagnosing and treating
disease. A total of 33 diseases are covered, and the disease scope this year includes maternal conditions
and neonatal infections.

Following is the ratings for the year 2012

Access to Medicine Index 2012

GlaxoSmithKline remains at the top of the Index, with a marginal improvement in performance since 2010, and this year, Johnson & Johnson and Sanofi follow closely in 2nd and 3rd positions. The top two companies have the most consistent approach to improving access to medicine, in terms of Index measurements – GlaxoSmithKline leads in four out of the seven key areas and is in the top three in others, and Johnson & Johnson is among the top five performers across all categories. Sanofi leads in public policy, and is second in three other areas; only its ninth position in patents and licencing and eighth position in pricing, manufacturing and distribution puts its overall score at third.

Source: Access to Medicine Index 2012

GSK outlines new plan to drive recruitment & attract graduate talent in UK

GlaxoSmithKline (GSK) outlined new plans to encourage talented students graduating from UK universities to consider pursuing a career within the company. These measures are part of the company’s ongoing efforts, as one of the leading FTSE companies and employers in the UK, to ensure the ongoing success of the business.

Each year, GSK currently recruits between 50-100 undergraduate students from various academic disciplines into its UK Graduate Training Programmes or other roles within the company.

Successful applicants are already offered highly competitive compensation packages. However, it is anticipated that forthcoming changes to tuition fees proposed by the UK Government will result in students incurring uncapped fees of up to £27,000 for a three-year undergraduate degree course (£9,000 per year).

As a result, GSK has taken the decision to reimburse 100 per cent of uncapped tuition fees for all undergraduates recruited in the UK. These payments will be made upon the commencement of full employment and will be conditional on the employee remaining with the company for a minimum of two years.

Uncapped fees, which are subject to Parliamentary approval, are expected to come into effect from September 2012. The timeline for the introduction of this new measure by GSK will mirror the Government’s timeline, and will be offered to students incurring uncapped fees commencing in September 2012.

These changes are being introduced as part of the company’s ongoing efforts to attract, recruit and retain the best talent and reflect the changing environment in the UK for students. The company believes these measures will help ensure that GSK remains a highly desirable place for graduates to consider working upon leaving university.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.