Asthma, U.S. and globally, is one of the most common, chronic health conditions, currently affecting an estimated 7.1 million children under age 18 years.1 Asthma is also the third leading cause of hospitalization among children under the age of 15.2 Epidemiological studies have shown that while there are many roads that lead to the development of childhood asthma, genetic and environmental factors are thought to be the most important. In looking forward, it is estimated by 2025, there will be an additional 100 million total people with asthma.3
In looking at clinical trial activity in the last five years in pediatric asthma, there have been many clinical pediatric asthma trials resulting in pediatric drug approvals, though there is still a gap in some countries where asthma prevalence exceeds 7% of the total population.
In order to address this concern, Figure 1 below contains a disease prevalence map highlighting countries with a high prevalence of asthma and the number of pediatric clinical trials conducted within those countries in the past five years.
Future Opportunities – Where should we be headed?
Figure 1: Source: http://www.asthmacure.com/wp-content/uploads/2010/11/asthma-prevalence3.jpg and Citeline’s Trialtrove (accessed 5/11/15)
Countries with a >10% total asthma population are highlighted red along with their total number of pediatric trials in the last 5 years. Similarly, those countries with an asthma population >7% but less than 10% are highlighted in orange along with their total number of pediatric trials within the last 5 years.
Many of the countries with a high asthma population (red and orange) have had very few pediatric trials conducted within the last five years which has not led to further the development of new approved pediatric drugs in these highlighted countries.
The International Study of Asthma and Allergies in Childhood (ISAAC) has consistently identified Australia, UK, New Zealand and Ireland as having the highest prevalence rates of asthma in children, especially those who live in remote locations.4 An additional ISAAC study concluded Brazil’s high prevalence in the disease has such an impact on children, that it should be seen as a public health problem.5
Why such a small number of pediatric trials in these high prevalence countries? When we look at the age range for asthma trials, any trials involving youth and adolescents ages 12 to 18 have to be excluded from the true pediatric patient population. The industry defines the pediatric population for asthma trials from age range 0 to 11 years. The challenge to launch new asthma drugs for this population is that asthma medicine needs to first be tested and approved in adults before pediatric trials can be conducted. The question is, are there adequate adult approved asthma medicines in these countries of high asthma prevalence? A quick look at the graph below shows mixed results.
Source: Citeline’s Pharmaprojects and Trialtrove
Figure 2 above shows there are clinical trial opportunities for pediatric patients in Brazil, Peru, S. Africa, Australia, Finland, Turkey, UK, and Canada where there are already a sizable number of adult drugs on the market for asthma. With the exception of the USA and UK, there are few asthma drugs already on the market for pediatric patients in the high prevalence countries. Ireland is an untapped resource where there are 35 adult approved asthma drugs but 0 pediatric related trials in the last five years and only three asthma drugs approved for pediatric use.
Forward looking, the total number of planned pediatric asthma trials in Citeline’s Trialtrove are listed at 2 (1) South Africa and (1) Canada. The industry has opportunities to close the gap of pediatric trials which can lead to additional medicines approved in the high asthma prevalence countries.
1 Source: http://www.lung.org/lung-disease/asthma/resources/facts-and-figures/asthma-children-fact-sheet.html
2 Source: http://www.pediatricasthma.org/about/asthma_burden
3 Source: http://www.ginasthma.org/local/uploads/files/GINABurdenReport_1.pdf
4 Source: http://www.asthmaaustralia.org.au/Statistics.aspx
5 Source: http://www.who.int/mediacentre/factsheets/fs206/en/