The FDA approved atogepant (Qulipta, AbbVie), on 9/29/2021, for the prevention of episodic migraine. The most common adverse events with atogepant are constipation, nausea and fatigue.
The FDA approved maralixibat (Livmarli, Mirum Pharmaceuticals), on 9/29/2021, for the treatment of cholestatic pruritus in patients with Alagille syndrome. Maralixibat will only be available through the Mirum Access Plus (MAP) program, a single-source specialty pharmacy owned by Mirum Pharmaceuticals.
Biogen and Eisai initiated a rolling BLA submission for lecanemab for the treatment of early Alzheimer's disease.
The FDA accepted the NDA for 177Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer, which suggested a PDUFA date of 3/29/2022.
Announced Research Updates
Pfizer is evaluating fordadistrogene movaparvovec as treatment for Duchenne muscular dystrophy in a 99 patient, Phase III trial. Due to three cases of muscle weakness and heart inflammation in two of the cases, Pfizer is amending the Phase III trial protocol to exclude patients with mutations affecting exons 9 through 13, or a deletion that affects both exon 29 and exon 30.
BE BRIGHT is a long-term extension of the BE READY, BE VIVID and BE SURE trials. UCB announced that in the 1,355 patient, open-label, Phase III, BE BRIGHT trial, treatment with bimekizumab resulted in PASI 90 being achieved by 91% of BE SURE patients who had originally received bimekizumab and 72.3% achieving PASI 100 at 104 weeks. Similar response rates were achieved by patients switched from adalimumab in BE SURE to bimekizumab in BE BRIGHT. 69.9% of BE VIVID patients switched from ustekinumab to bimekizumab achieved PASI 100 at week 100.
Lilly announced that in the 52-week, 243 patient, SURPASS-3 CGM sub-study, 72.6% of patients treated with tirzepatide maintained blood glucose in the target range of 71-140 mg/dL compared to 48% of patients treated with insulin degludec. Tirzepatide patients also spent less time in the hypoglycemia range of 70 mg/dL or less (0.6% vs 1.0%).
Lilly announced that in a 104-week, Phase II trial, 186 patients with moderate-to-severe active ulcerative colitis (UC) received mirikizumab for 12-weeks. 93 patients responded and were randomized to mirikizumab every 4 weeks or every 12 weeks. After 52-weeks, 92.5% (86/93) continued taking mirikizumab and 82.1% achieved rectal bleeding remission and 84.6% achieved stool frequency remission. After two years, 83.9% remained on mirikizumab with 85.9% maintaining rectal bleeding remission and 84.6% maintaining stool frequency remission.
Published Research Updates
In the 69 patient, Phase IlI, FOCUS4-C trial, treatment with adavosertib improved progression free survival compared to active monitoring (3.61 vs 1.87 months) in metastatic colorectal cancer patients with TP53 and RAS mutations.
A 143 patient, Phase II trial was stopped early when an interim analysis of the first 123 patients found no improvement in overall survival when adding veliparib to mFOLFIRI compared to FOLFIRI alone (5.4 vs 6.5 months) in patients with metastatic pancreatic cancer.
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