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.
Merck and its partner Healthy Interactions launched a newly updated unbranded digital diabetes app called Map4health. Previously, the app was available with fewer features under the name “Conversation Map.” Interestingly, the platform can be used by both patients and HCPs; however, Merck and Healthy Interactions are primarily marketing the platform to HCPs with the intent to drive patient uptake through HCP recommendations. Below, FENIX provides an overview of the app features as well as thoughts on the program.
Based on the recent AZ announcement for the initiation of a Farxiga HFpEF Ph3b study, FENIX has updated its previous SGLT2i heart failure CVOT tale-of-the-tape analysis (published June 1, 2018) and projected timeline for filings and launches.
Late last week, AZ announced a new HF CVOT for Farxiga named DELIVER. Curiously enough, the news was not seen on any global newswires. Below, FENIX provides its thoughts on the trial, including the checkered past of Scott Solomon and the choice of him as PI on DELIVER.
Janssen announced CHMP has granted a positive opinion to update the Invokana and Vokanamet labels to include data on the reduction of 3P-MACE in patients with T2DM and a history of CVD or at least 2 risk factors.
According to court documents, AZ has dismissed its lawsuit against Zydus Pharmaceuticals over Zydus’ generic Farxiga filing in the US. The suit was initially filed with the US District Court, New Jersey on May 3, 2018 and claimed infringement on two AZ patents (6,414,126 and 6,515,117). Interestingly, the suit was dropped even though Zydus did not answer AZ’s complaint or filed a motion for summary judgment. It is unclear as to why AZ decided to withdraw its lawsuit vs. Zydus; however, AZ and Zydus may have come to an agreement outside of the courts. Below, FENIX provides an analysis based on the FDA Orange Book and Paragraph IV filings.
Lexicon hosted its Q2 ’18 earnings call and provided updates on sotagliflozin. Discussion centered on the potential FDA adcom for sotagliflozin in T1DM, DKA consensus guidelines being developed by ATTD, and the benefit of sotagliflozin in reducing hypoglycemia.
Biocon hosted its CY Q2 ’19 (FY Q1 ’19) earnings call and provided an update on its biosimilar glargine development program including the CRL that was issued in early June 2018. Additionally, Merck hosted its Q2 ’18 earnings call and briefly touched on its diabetes business unit. Below, FENIX provides an overview of the calls and insight on Biocon’s glargine CRL.
AZ hosted their Q2 ’18 earnings call and briefly discussed their diabetes portfolio, with particular focus on Farxiga and the upcoming DECLARE CVOT results.