- An FDA panel recommended approval of Teva's asthma drug reslizumab for adults but voted unanimously to not approve the medication for children between the ages of 12 and 17.
- Reslizumab is an antibody medication administered intravenously once every four weeks.
- The panelists thought the sample size of pediatric patients in Teva's trial was not sufficient as a basis for approval in this cohort. In addition, there were red flags associated with two safety issues—anaphylaxis and muscle toxicity.
With more than 22 million people in the U.S. with the condition, asthma is a very lucrative therapeutic area. The IL-5 class of drugs represents a very effective anti-inflammatory approach to treatment.
But, Teva is not the only player in this space. AstraZeneca and Regeneron/Sanofi are in phase 3 with their IL-5 antibodies, while GlaxoSmithKine won approval for its IL-5 antibody drug, Nucala, last month. Notably, Nucala was approved for patients 12 and older, giving GSK a competitive advantage over Teva.
It is possible Teva could go after the initial adult indication and then pursue an additional pediatric indication after conducting more clinical trials. Market analysis pegs potential earnings per year at over $1 billion.