Breo Ellipta Review Pits Clinical Benefits Against Statistical Shortcomings
FDA advisory committee majority favored approval of GlaxoSmithKline’s fluticasone furoate/vilanterol combination for COPD despite the failure, under a prespecified statistical analysis plan, to demonstrate significant results on all primary endpoints. GSK is developing the drug with Theravance.
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Theravance could soon have its first substantial revenue generator on the market, the COPD therapy Breo Ellipta partnered with GlaxoSmithKline. The launch of Breo is just one of several catalysts expected to unfold for the biotech in 2013.
Agency is working with manufacturers, including Takeda and Emergent BioSolutions, to accelerate development of hyperimmune globulin products, with an eye toward starting clinical testing in several months; new FDA guidelines on convalescent plasma collection for single-patient emergency IND use are helpful in understanding agency expectations around source plasma collection for manufactured products as well, Emergent SVP Laura Saward says.
Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.