The FDA approved the combination of olanzapine and samidorphan (Lybalvi, Alkermes), on 6/1/2021, for the treatment of schizophrenia and bipolar 1 disorder. Olanzapine and samidorphan were approved with a Black-Box warning regarding increased risk of mortality in elderly patients with dementia-related psychosis.
The FDA approved ibrexafungerp (Brexafemme, Scynexis), on 6/2/2021, for the treatment of vulvovaginal candidiasis in adults and post-menarchal pediatric females.
The FDA accepted the NDA for BeyondSpring’s plinabulin to be used in combination with a granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia and set a PDUFA date for 11/30/2021.
The FDA accepted the NDA for CTI BioPharma’s pacritinib to treat myelofibrosis with severe thrombocytopenia and set a PDUFA date for 11/30/2021.
The FDA accepted the NDA for Akebia’s and Otsuka’s vadadustat for the treatment of anemia due to chronic kidney disease in both dialysis dependent and non-dependent patients and set a PDUFA date for 3/29/2021.
The FDA accepted the NDA for Amryt’s oleogel-S10 for the treatment of the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa and set a PDUFA date for 11/30/2021.
AB Science is suspending clinical trials of masitinib to investigate the drug’s potential risk of ischemic heart disease, which was identified in a retrospective analysis of clinical data.
Liminal discontinued development of fezagepras for the treatment of Idiopathic pulmonary fibrosis and hypertriglyceridemia after disappointing pharmacokinetic studies.
Dermavant submitted an NDA for tapinarof cream for the treatment of plaque psoriasis.
Announced Research Updates
Santhera and ReveraGen announced that in the 24-week, 121 patient, Phase IIb, VISION-DMD trial, patients treated with vamorolone 6 mg/kg/day improved the time from supine positioning to standing by 1.4 seconds compared to a 0.1 second deterioration with placebo in boys aged 4 to 7 years with Duchenne muscular dystrophy.
Novartis announced that in the 831 patient, open-label, Phase III, VISION trial, patients treated with Lu-PSMA-617 plus standard of care achieved progression free survival of 8.7 months and overall survival of 15.3 months compared to 3.4 months and 11.3 months with standard of care alone in patients with advanced stage PSMA-positive metastatic castration-resistant prostate cancer.
Coherus BioSciences and Junshi Biosciences announced interim results from the 289 patient, Phase III, JUPITER-02 trial, where patients treated with toripalimab plus gemcitabine and cisplatin followed by toripalimab maintenance therapy achieved progression-free survival of 11.7 months compared to 8 months with gemcitabine and cisplatin alone followed by placebo maintenance treatment in Chinese patients with recurrent or metastatic nasopharyngeal carcinoma.
Biosight announced interim data from 46 patients enrolled in a Phase IIb trial, where treatment with aspacytarabine resulted in a 39% complete response rate in patients with acute myeloid leukemia who are not eligible for standard induction chemotherapy due to advanced age or comorbidities.
BeiGene announced results from the 512 patient, open-label, Phase III, Chinese RATIONALE 302 trial, where treatment with tislelizumab improved overall survival compared to investigator’s choice of paclitaxel, docetaxel or irinotecan (8.6 months vs 6.3 months) in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma.
LSKB and Hengrui announced that after 10.8 months in the 596 patient, Phase II, ESCORT-1st trial, treatment with camrelizumab plus paclitaxel and cisplatin resulted in overall survival of 15.3 months and progression-free survival of 6.9 months compared to 12 months and 5.6 months with paclitaxel and cisplatin alone in Chinese patients with untreated advanced or metastatic esophageal squamous cell carcinoma.
Legend Biotech announced data after 18-months in the 97 patient, Phase Ib/II, open-label, CARTITUDE-1 trial, where ciltacabtagene autoleucel demonstrated an overall response rate of 98% and complete response of 80% in patients with relapsed multiple myeloma. Legend Biotech announced interim data from 20 patients after 5.8 months in the 120 patient, Phase II, open-label, CARTITUDE-2 trial, where ciltacabtagene autoleucel demonstrated an overall response rate of 95% and complete response of 75% in patients with progressive multiple myeloma after 1-3 prior lines of therapy, who were refractory to lenalidomide. The FDA accepted the BLA for ciltacabtagene autoleucel for the treatment of relapsed and/or refractory multiple myeloma and set a PDUFA date for 11/29/2021.
Published Research Updates
In the 24-week, 424 patient, Phase III, DOLOMITES trial, 89.5% of patients treated with roxadustat achieved hemoglobin of at least 11.0 g/dL and hemoglobin change from baseline of at least 1.0 g/dL compared to 78% that received darbepoetin in non-dialysis-dependent CKD patients with anemia.
The 58-week, 1,348 patient, Phase IIb/III, SELECTION trial evaluated filgotinib as a treatment of moderately to severely active ulcerative colitis. During the 10 week induction phase of the trial patients received filgotinib 100 mg, 200 mg or placebo. Treatment with filgotinib 100 mg did not differ from placebo in the percentage of patients achieving remission. However, compared to placebo remission was achieved in more biologic-naive patients treated with filgotinib 200 mg (26.1% vs. 15.3%) and in biologic-experienced patients (11.5% vs. 4.2%). The 664 patients that achieved remission were re-randomized to filgotinib or placebo for an additional 48 weeks. In the maintenance part of the trial, 37.2% of patients treated with filgotinib 200 mg and 23.8% that received 100 mg maintained clinical remission compared to 11.2% with placebo.
In the 24 week, 1,315 patient, Phase III MINDSET study, adding intepirdine to donepezil did not improve the ADAS-Cog or ADAS-ADL scores compared to donepezil alone in patients with mild-to-moderate Alzheimer’s disease dementia.
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