Prescribe Right Pharmaceutical Pipeline Update for August 9

Eleven Items of Interest from over 200 Informational feeds from around the Pharmaceutical industry.

• The FDA approved Progenics Pharmaceuticals’ iobenguane I 131 for the treatment of pheochromocytoma or paraganglioma on July 30, 2018.
• The FDA approved Shionogi’s lusutrombopag (Brand name: Mulpletaon) on July 31, 2018, for the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.
• Quizartinib (Ambit Biosciences Corporation, Daiichi Sankyo) was awarded Breakthrough status by the FDA.
• In a 40-patient, Phase II trial, treatment with apatinib (by Jiangsu Chiatai Qingjiang & Advenchen) resulted in a PFS of 3 months and overall survival of 7.7 months in heavily pretreated patients with advanced non-squamous non-small-cell lung cancer. Also, in a 437-patient, Phase III trial, anlotinib improved overall survival versus placebo in pretreated patients with advanced NSCLC. An analysis of this same patient population found that anlotinib improved quality of life compared to placebo.
• In a 24-week, 314 patient, Phase II trial, patients treated with baricitinib (Lilly, Incyte) 4mg had a resolution of arthritis or rash at week 24, as defined by Systemic Lupus Erythematosus Disease Activity Index-2000, compared to placebo in patients with systemic lupus erythematosus. The 2mg dose failed to show an improvement compared to placebo.
• Redhill announced that in a 26-week, 331 patient, Phase III trial, treatment with RHB-104 resulted in 37% of patients achieving compared to 23% with placebo in patients with Crohn’s disease. However, at 52 weeks the results were no longer statistically significant (27% for RHB-104 vs 20% for placebo).
• Active Biotech announced that in a 12-month, 331 patient, Phase II trial, laquinimod did not improve the Unified Huntington's Disease Rating Scale - Total Motor Score compared to placebo.
• Otsuka announced that in the 815 patient, Phase III, ASTRAL-1 trial, guadecitabine did not improve the complete response or overall survival rates compared to azacitidine, decitabine or low-dose cytarabine in treatment naive patients with acute myeloid leukemia.
• Astex is assessing guadecitabine in the ongoing Phase III ASTRAL-2 (acute myeloid leukemia) and ASTRAL-3 (myelodysplastic syndromes and chronic myelomonocytic leukemia) trials.
• Nektar has submitted an NDA for NKTR-181 with a PDUFA date of May 28, 2019.
• Conatus announced that in a 3-month, 74 patient, Phase II trial, patients that received emricasan had similar MELD scores, INRs and total bilirubin compared to placebo in patients with cirrhosis. A reduction in MELD score, INR and total bilirubin compared to placebo was seen in 9 patients with MELD scores of 15 or higher.