On Thursday, an FDA advisory committee recommended approval for reslizumab, Teva Pharmaceutical’s experimental asthma drug. If approved, the drug will compete with GSK’s Nucala (mepolizumab), another treatment for severe asthma.
Nacala was approved in November for use in combination with other asthma drugs in patients with severe asthma aged 12 and older.
According to Medical Marketing and Media, the panel voted 11-3 in favor of approving the drug for use in adults, but it voted unanimously against approval in children ages 12 years old to 17 years old, citing concerns about efficacy and safety in that age group, as well as the small number of young patients included in the clinical trial.
Mepolizumab and reslizumab are antibodies that work to prevent asthma from worsening by binding and neutralizing the humanized interleukin-5 (IL-5), a group of proteins that regulate immune response. IL-5 plays a role in chronic airway inflammation present in eosinophilic asthma, a type of asthma characterized by poor control over the disease and lower lung function even if patients are using a corticosteroid inhaler to manage their symptoms.
Between 30% and 40% of patients with asthma have the eosinophilic form of the disease, according to Dr. Mario Castro, professor of medicine and pediatrics at the Washington University School of Medicine and a presenter at Wednesday's committee hearing, reported Medical Marketing & Media.
AstraZeneca is also testing its IL-5 inhibitor and antibody, benralizumab, which is currently in Phase-III trials.
The first biologic drug for severe asthma was Xolair (omalizumab), marketed by Roche and Novartis, but it is approved for a different type of severe asthma. Xolair generates $2 billion in sales annually.
Our Take: Watch this category of specialty drugs closely. According to the CDC, 18.7 million adults (about 8%) have asthma, which means about 6.5 million adults have the eosinophilic form of the disease. At $1,000 per year—an unlikely, low estimate of the product’s price— the market for IL-5 inhibitors would be about $6.5 billion.
Priced closer to Xolair, which runs between $10,000 and $16,000 annually, that’s $65 -$100 billion per year.
Good intelligence on pricing for either compound isn’t yet available. But this new class of drugs could become the budget-buster for 2016 that we saw for other specialty pharma products over the last 18 months.