The briefing documents for the June 20, 2017 LEADER adcom were posted by the FDA. Recall, Novo Nordisk submitted the sNDA efficacy supplement for Victoza (liraglutide 1.8 mg) on October 25, 2016, which suggests the PDUFA date will be on or around August 25 following a 10-month review.
Results of the CV outcomes trials meta-analysis for canagliflozin, CANVAS and CANVAS-R, were published in the NEJM in conjunction with the data presentation at ADA ’17. A one-hour session reviewed background and trial design including the study population and integrated analysis methods, CV outcomes, renal outcomes, safety, and context.
During Apple’s keynote presentation at the Worldwide Developers Conference (WWDC), Kevin Lynch, Apple’s VP Technology, mentioned that the iWatch is able to receive real-time CGM data from Dexcom CGMs. Dexcom’s stock rose over 4% after the announcement.
An ADA abstract titled “A Novel Formulation of Insulin Lispro Containing Citrate and Treprostinil Shows Faster Absorption and Improved Postprandial Glucose Excursions vs. Humalog in Patients with T1DM” will be presented by Lilly at the General Poster Session on June 10, 2017.
J&J hosted their pharmaceutical business review and provided commentary on the Invokana boxed warning, CANVAS/R and CREDENCE, and their pipeline dual GLP-1/glucagon agonist from Hanmi.
FDA has issued a Drug Safety Communication regarding an increased risk of lower limb amputations associated with canagliflozin therapies (Invokana, Invokamet, Invokamet XR) based on results from the CANVAS CV outcomes study. As such, FDA is requiring a Boxed Warning to be added to the labels of the respective drugs.
MannKind held its Q1 2017 earnings call and provided updates on commercial and clinical activities for Afrezza.
Lexicon has announced additional positive data from the Ph3 inTandem1 study. Of note, a slight increase in DKA was seen in the sotagliflozin groups during the extension period with 6 cases (2.5%) on 200mg and 3 cases (1.3%) for 400mg compared to 1 patient (0.4%) on placebo.
On May 10th, Mylan hosted its Q1 2017 earnings call and briefly discussed its insulin glargine development program.
MannKind Corporation and One Drop are entering into a collaborative agreement that would extend One Drop’s subscription service and digital health platform through the addition of Afrezza as a rapid-acting insulin offering integrated in-app with Bluetooth technology.