Prescribe Right Pharmaceutical Pipeline Update for September 26

Thirty-one citations were added to our knowledgebase bringing the total to 809. Each citation is accessible from the single drug look-up monograph via a URL link. There are now 612 investigational drugs in the Knowledgebase.

Two Updates on products with PDUFA Dates and/or Priority Designations
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of Lilly’s galcanezumab. The FDA has Fast-Tracked the drug with a review date next week, September 30, 2018.

J&J announced that in a 4-week, 346 patient, Phase III trial, esketamine nasal spray added to a new anti-depressant did not improve Montgomery-Asberg Depression Rating Scale (MADRS) total score compared to monotherapy with a new antidepressant in patients with treatment-resistant depression. No PDUFA date but the drug has a Breakthrough Therapy Priority Designation.

Five additional updates:

• A pooled analysis of 3,492 patients in 8 trials involving baricitinib (Lilly, Incyte) found mortality, cardiovascular events and serious infection rates similar to placebo. Brand name: Olumiant.
• Astellas announced topline results from a 52-week, Phase III trial in which roxadustat achieved a hemoglobin response rate in the first 24 weeks and hemoglobin change from baseline at Weeks 28 to 52 compared to placebo in CKD patients with anemia. 
• Novo Nordisk announced that in a Phase III trial, daily oral semaglutide lowered HbA1c 1.8% with 14mg, 1.4% with 7mg and 0.7% with 3 mg compared to a 1.3% reduction with weekly dulaglutide 0.75 mg in Japanese type 2 diabetic patients. The effect on weight with semaglutide was a 1.9 kg loss with 14 mg, 1 kg loss with 7mg and a 0.1 kg weight gain with 3 mg compared to a 1.1 kg gain with dulaglutide.
• In a 390-patient, open label trial involving dengue naive US adults, use of a compressed vaccination schedule (0-2-6 months) was comparable to the standard scheduled (0-6-12 months) given with or without concomitant yellow fever vaccine. Patients that received the compressed schedule were 73.4% seropositive for ≥3 serotypes and 50% seropositive for all four serotypes compared to 82.4% and 42.6% for the standard schedule.
• In a 37-month, 1,147 patient, Phase III trial, treatment with Novartis’ buparlisib plus Astra Zeneca’s fulvestrant (FDA approval date 11/15/2017) was no better than fulvestrant monotherapy in overall survival of the total population or patients with PIK3CA-mutant ctDNA.

You can access up-to-date information on all drugs in the late stages of development with the Prescribe Right Pharmaceutical Pipeline Tracker.