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Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) revealed that it received a positive opinion from European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for its CINQAERO. The drug is a humanized interleukin 5 antagonist monoclonal antibody for add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
Teva Global Specialty Medicines President and CEO, Rob Koremans, commented, "As a company committed to providing medicines and solutions for people around the world living with respiratory disease, Teva is very pleased to report a positive opinion by CHMP for the first intravenous anti-IL-5 biologic therapy for severe eosinophilic asthma."
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He continued, "In clinical trials, reslizumab was effective in reducing asthma exacerbations, improving lung function and improving asthma-related quality of life measures. It is our hope that we can expand the availability of reslizumab globally and soon bring this important treatment option to a specific group of severe eosinophilic asthma patients in Europe who struggle to control their symptoms despite today's standard of care."
Teva indicated the CHMP opinion was based on review of a Marketing Authorization Application (MAA) containing efficacy, as well as safety data from its global development program in asthma. The company added that its clinical trial program comprised of five placebo-controlled trials that illustrated the efficacy and/or safety profile in a population of 1,028 adult and adolescent asthma patients treated with reslizumab 3 mg/kg that were inadequately controlled with inhaled corticosteroid (ICS)-based therapies.
The drug maker said that CHMP positive opinion was a formal recommendation to grant marketing authorization for reslizumab. The company said that the recommendation would now be reviewed by the European Commission and the final decision is expected in the second half of the current year.
In the pre-market trading on Friday, the stock traded 3.04 percent down.
27% profit every 20 days?
This is what Nic Chahine averages with his option buys. Not selling covered calls or spreads… BUYING options. Most traders don’t even have a winning percentage of 27% buying options. He has an 83% win rate. Here’s how he does it.