With no PDUFA decisions on the plate this week, we’ll instead turn our attention to two important FDA panel meetings and two earnings reports that simply can’t be missed.
On Monday, Depomed Inc (NASDAQ:DEPO) is expected to go before the FDA panel with its menopausal hot-flash drug, Serada. As TheStreet.com’s Aafia Chaudrey noted in early February, DepoMed’s first two Breeze trials were largely unsuccessful, with neither hitting their primary endpoints and dropout rates running very high. The Breeze-3 trial, from which this new drug application originates, demonstrates a reduction and frequency of hot flashes relative to placebo but still showed a higher number of patients dropping out of the trial because of adverse events than the placebo (16.7% to 11.5%). It’s really difficult to tell how the FDA’s panel will perceive this data at the moment.
Later in the week, on Thursday, GlaxoSmithKline plc (ADR)(NYSE:GSK) and Theravance Inc (NASDAQ:THRX) will face the FDA panel with their long-term COPD solution, Breo Ellipta. The inhaled drug combines a long-acting beta agonist with a once daily inhaled corticosteroid to provider 24-hour relief to COPD suffers. In two mid-stage trials spanning 1,620 patients, the first trial demonstrated statistical significance at all three dosing levels, while the second demonstrated statistical significance at the lowest and mid-tiered dosing level. Both studies exhibited a reduction in COPD exacerbations, though not all figures were numerically significant. In short, GlaxoSmithKline plc (ADR)(NYSE:GSK) and Theravance Inc (NASDAQ:THRX) could have a blockbuster on their hands, as long as the FDA panel feels the results show a marked improvement over existing treatments. Thursday is a key day for these two companies!