A Ph1 CT.gov record evaluating a new triplet FDC of empa+lina+met XR has been observed. Below, FENIX provides further details on potential triplet FDC filings and analysis, including pricing, based on read-through from the SGLT2i+DPP-IVi FDC market.
FDA issued a warning for the risk of a rare genital infection (necrotizing fasciitis of the perineum aka Fournier’s gangrene) with the use of SGLT2 inhibitors. FDA is also requiring label updates for the class. According to the FDA’s warning letter, there have been 12 cases (7 males and 5 females) of Fournier’s gangrene from March 2013 to May 2018.
Sanofi and Pfizer hosted their respective Q2 ’18 earnings calls. Sanofi only briefly discussed its diabetes business including continued headwinds for its glargine franchise. Of note, Sanofi has recently updated the name of its efpeglenatide CVOT to “AMPLITUDE-O.” Pfizer did not discuss its Steglatro (ertugliflozin) franchise; however, in the pipeline update, it was noted that PF-06342674 (IL-7 receptor precursor modulator) for the treatment of T1DM has been discontinued. Below are highlights from the respective calls.
FENIX has conducted a pricing analysis of the SGLT2i and SGLT2i+DPP-IVi FDC classes.
Merck/Pfizer quietly filed their SGLT2i, ertugliflozin, FDC with metformin, and FDC with Januvia (sitagliptin) in December 2016.