Zurich: Roche suffered a setback in its ambitions to build its presence in the emerging market for biotech asthma drugs on Monday when it announced that one of two identical studies failed to help patients as expected.
The Swiss drugmaker said while the first final-stage Phase III study of lebrikizumab in people with severe asthma met its primary endpoint and significantly reduced exacerbations, the second did not.
“We were hopeful these identical studies would confirm the Phase II results because there is still a significant unmet need for people with severe asthma,” Chief Medical Officer and Head of Global Product Development Sandra Horning said in a statement.
“These data require further interpretation and analyses are ongoing to better understand the results and determine next steps.”
Lebrikizumab, an injectable antibody drug that works by blocking a protein called interleukin-13, is designed to compete in a market for severe asthma treatments that analysts expect to be reasonably crowded. As a result, there is little for error in proving the benefits of lebrikizumab.
Xolair, which was jointly developed by Roche and Novartis , was until recently the only biotech medicine approved for severe asthma patients. But GlaxoSmithKline has now launched a promising new product called Nucala and several other companies are working on rival biotech asthma drugs.
There was better news for Roche on another front late on Friday when U.S. regulators granted approval for its drug Gazyva for certain people with previously treated follicular lymphoma.