New Drug Update for The Week Ending June 22

Regulatory Update

The FDA approved AMAG Pharmaceuticals’ bremelanotide (Vyleesi) on 6/21/2019 for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder.

In June 2019, the FDA rejected Daiichi Sankyo’s quizartinib (Vanflyta), following the recommendation of the Oncology Drug Advisory Committee, which voted 3 to 8 against approval in May 2019.

Bluebird plans to delay its launch of beta beglogene darolentivec until 2020 to finalize a manufacturing process to support a commercial launch.

Trevena initiated a safety trial to evaluate QT-interval prolongation with oliceridine to meet an FDA requirement to refile an NDA.

Announced Research Updates

Geron announced that in the 24-week, 38 patients, Phase II/III, open label, IMerge trial, 42% of patients treated with imetelstat achieved transfusion independence at 8 weeks (primary endpoint) and 29% remained transfusion independent at 24 weeks in heavily transfusion-dependent patients with myelodysplastic syndrome.

Epizyme announced interim data from 96 follicular lymphoma patients enrolled in a Phase II trial, treatment with tazemetostat resulted in an objective response rate in 77% of 43 patients with EZH2 activating mutations and 34% of 53 patients with wild-type EZH2.

Published Research Updates

In a 16-week, 63 patient, Phase III trial, treatment with Mezzion/Allergan’s udenafil increased 6-min walking distance by 25 meters in patients with pulmonary arterial hypertension.

In a 24-month, 35 patient, Phase II, extension trial, annualized growth velocity from treatment with BioMarin Pharmaceutical’s vosoritide was maintained for up to 42 months.

The 706 patient, Phase III, ECHO-301/KEYNOTE-252 trial was stopped after the second interim analysis when Incyte’s epacadostat added to pembrolizumab did not improve progression free survival or overall survival compared to pembrolizumab monotherapy in patients with unresectable or metastatic melanoma. 

In a 24-week, 56 patient, Phase III, open-label trial, AstraZeneca/FibroGen’s roxadustat maintained target hemoglobin levels in peritoneal dialysis patients who were previously treated or not treated with erythropoiesis stimulating agents.