New Pipeline Updates from Merck, Sandoz, Genentech and Gilead

November 5, 2018

Company Drug/Device Medical Condition Status
Aquestive Therapeutics, Inc. SYMPAZAN™ (clobazam) Seizures associated with Lennox-Gastaut syndrome (LGS) in
patients 2 years of age or older
Granted approval by the FDA
Sandoz Hyrimoz (Adalimumab), biosimilar to AbbVie’s Humira Metastatic squamous non-small cell lung cancer (NSCLC) Granted approval by the FDA
Merck Keytruda Metastatic squamous non-small cell lung cancer (NSCLC) FDA has approved, in combination with chemotherapy, as a first-line treatment
Cerus Corporation Pathogen-reduced cryoprecipitate Massive hemorrhage Granted Breakthrough Device designation by the FDA
Alkermes ALKS 5461 Depression FDA advisory committee rejected New Drug Application
Genentech Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) Previously untreated chronic lymphocytic leukemia (CLL) and
co-existing medical conditions
Randomized Phase III CLL14 trial met its primary endpoint; showed a statistically significant reduction in risk of disease worsening or death compared to standard-of-care Gazyva plus chlorambucil
Genmab and Johnson & Johnson’s Janssen Darzalex (daratumumab) Multiple myeloma In Phase III MAIA trial, met its primary endpoint of improved progression-free survival (PFS) at a pre-planned interim analysis
Bio-Thera Solutions, Ltd. HER2 Antibody-Drug Conjugate (ADC), BAT8001 HER-2 positive metastatic
breast cancer
Initiated Phase III clinical trial evaluating the efficacy and safety
Gilead Sciences, Inc. Biktarvy®
(bicte-gravir 50 mg/emtricitabine 200 mg/tenofovir alafen-amide 25 mg tab-lets, BIC/FTC/TAF)
HIV-1 infection Results from Phase III randomized, double-blinded trial; found to be statistically non-inferior to a regimen of dolutegravir and emtricitabine/tenofovir alafenamide (50 mg) (DTG+FTC/TAF) through 96 weeks of therapy