FDA Will Review Teva’s BLA for Asthma Drug Reslizumab
Reslizumab, an anti-IL-5 antibody
Teva Pharmaceutical Industries’ (TEVA) reslizumab is an investigational humanized monoclonal antibody targeting interleukin-5 (or IL-5). The drug is designed to reduce exacerbations, relieve symptoms, and improve lung function for people with asthma and elevated blood eosinophils where inhaled corticosteroids are not effective. The FDA’s (U.S. Food and Drug Administration) Pulmonary-Allergy Drugs Advisory Committee will review the biologics license application based on results of BREATH, the Phase III clinical trial for reslizumab, on December 9, 2015
Phase III BREATH clinical trial
According to a Teva press release, the Phase III BREATH clinical trial included four placebo-controlled Phase III trials. These trials studied more than 1,700 asthma patients with elevated blood eosinophils where inhaled corticosteroids were not effective.
Two of the Phase III trials studied ~950 patients, from which nearly 50% received reslizumab for 12 months and the remaining 50% received a placebo. The results demonstrated that reslizumab reduced asthma exacerbation rates by at least half and significantly improved lung function. The secondary measures of asthma control improved significantly when reslizumab was added to existing inhaled corticosteroid-based therapies.
According to the press release, reslizumab had some adverse effects, but they were similar to the adverse effects of the people in the placebo group. The adverse effects included worsening of asthma, nasopharyngitis, upper respiratory infections, sinusitis, influenza, and headache.
GlaxoSmithKline’s (GSK) Advair Diskus, Merck & Co.’s (MRK) Singulair, AstraZeneca’s (AZN) Symbicort, and Teva’s ProAir series are other treatments for asthma. To divert the risk of investing in one company, investors can consider ETFs such as the PowerShares International Dividend Achievers ETF (PID) or the Market Vectors Pharmaceutical ETF (PPH), which hold investments in Teva.
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