GlaxoSmithKline said early Tuesday it commenced a phase III study evaluating mepolizumab in patients with severe bilateral nasal polyps, a chronic inflammatory disease of the nasal passage linings or sinuses. The drug maker said the study will evaluate the safety and efficacy of subcutaneous mepolizumab versus placebo in 400 adult patients with recurrent severe bilateral nasal polyps. The study is slated for completion in 2019.
Separately, GlaxoSmithKline said it received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for a new four-dose vial presentation of its Synflorix pneumococcal vaccine. The approval represents the first step in delivering the new vaccine presentation in developing countries. The new presentation is designed to significantly reduce storage needs in developing countries where cold-chain delivery can be challenging, the company said.