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|July 28, 2015 8:01 a.m.|
|Teva Announces European Medicines Agency (EMA) Confirms Successful Validation of Reslizumab Marketing Authorization Application|
JERUSALEM--(BUSINESS WIRE)--Jul. 28, 2015--
“Uncontrolled asthma remains a serious challenge for patients and healthcare professionals despite the availability of standard of care treatment,” said Dr.
The MAA for reslizumab includes data from Teva’s Phase III BREATH clinical trial program. The program consisted of four separate placebo-controlled Phase III trials specifically designed to include a targeted population of 1,700 adult and adolescent asthma patients with elevated blood eosinophils, whose symptoms were inadequately controlled with inhaled corticosteroid-based therapies. Results from these studies demonstrated that reslizumab, compared to placebo, reduced asthma exacerbation rates by at least half (50-60 percent) and provided significant improvement in lung function, quality of life and other secondary measures of asthma control as add-on therapy. Common adverse events in the reslizumab treatment group were comparable to placebo and included worsening of asthma, nasopharyngitis, upper respiratory infections, sinusitis, influenza and headache. Two anaphylactic reactions were reported and resolved following medical treatment at the study site.
“Through the development of novel molecules and inhaler devices, Teva is committed to delivering innovations in asthma care that help patients achieve improved asthma outcomes and quality of life,” said Rob Koremans, MD President and CEO of Teva Global Specialty Medicines. “We are delighted with this successful filing for reslizumab, which, if approved, will broaden and strengthen our respiratory offering and provide a much-needed new treatment for an underserved patient group.”
A final decision from the EMA on reslizumab is anticipated in the second half of 2016. A Biologics License Application (BLA) for reslizumab was also accepted by the
Reslizumab is an investigational humanized monoclonal antibody developed to target interleukin-5 (IL-5). IL-5 is a key cytokine shown to play a crucial role in the maturation, activation and survival of eosinophils, which are a type of white blood cell that are present at elevated levels in the lungs and blood of many asthmatics. Evidence shows that eosinophils play an active role in the pathogenesis of the disease. Increased levels of eosinophils in the sputum and blood have been shown to positively correlate with disease severity and increased risk of asthma exacerbations. Reslizumab acts by binding circulating IL-5 and preventing IL-5 from interacting with its receptor.
Asthma is a chronic (long term) disease usually characterized by airway inflammation and narrowing of the airways, the severity and prognosis of which can vary over time. Asthma may cause recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath and coughing that often occurs at night or early in the morning. Without appropriate treatment, asthma symptoms may become more severe and result in an asthma attack, which can lead to hospitalization and, in extreme cases, even death.
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our innovative products, especially Copaxone® (including competition from orally-administered alternatives, as well as from potential purported generic equivalents) and our ability to migrate users to our 40 mg/mL version; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and
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