The FDA approved lorlatinib (Lorbrena) on 11/2/18 for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) who have progressed on crizotinib and at least one other ALK inhibitor.
The FDA approved sufentanil sublingual tablets on 11/2/18 for the treatment of moderate-to-severe acute pain in certified medically supervised healthcare settings.
The FDA's Anesthetic and Analgesic Drugs Advisory Committee voted 8-7 against recommending approval of oliceridine in October 2018. The FDA rejected oliceridine in November 2018 and requested additional data on QT prolongation, a larger safety database and more nonclinical data and validation reports.
The FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Committee voted 21-2 against recommending approval of Alkermes' buprenorphine/samidorphan in a joint meeting in November 2018. The committee felt that efficacy had not been proven and studies had methodological problems, but in a narrow vote (13-10) indicated that safety had been demonstrated.
The FDA noted a loss of consciousness during infusion of brexanolone in 6 patients during clinical trials and recommended a REMS program and administration by a health care professional outside the patient’s home. In current data the increased risk for loss of consciousness/presyncope is 4%. The FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 17-1 this month that brexanolone demonstrated efficacy and 16-2 for safety in the treatment of postpartum depression.
The FDA granted Sanofi’s Dengvaxia dengue vaccine a priority review and set a PDUFA date of 5/1/2019.
Esperion announced results of a Phase III trial, where the addition of bempedoic acid to a statin resulted in MACE events of 6.1% compared to 8.2% with statin monotherapy in patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia. At 12 weeks, LDL was decreased an additional 18% with bempedoic acid compared to placebo. ADRs were similar with the addition of bempedoic acid to a statin compared to statin monotherapy.
Novartis announced results from two Phase III trials involving patients with AMD. Brolucizumab given every 3 months was non-inferior to aflibercept given every 2 months in best-corrected visual acuity at 48 weeks. Intra-retinal fluid and/or sub-retinal fluid was found in 24% of brolucizumab patients compared to 37% of aflibercept patients, while in HARRIER it was found in 24% of brolucizumab patients compared to 39% of aflibercept patients.
ViiV announced that in a Phase IIb Trial of cabotegravir and rilpivirine, 90% of patients that received the 8-week regimen and 83% of patients on the four-week regimen remained virally suppressed, while 97% and 100% of patents switched from an oral regimen remained virally suppressed. ViiV announced that in another Phase III trial, patients that were viral suppressed at 20 weeks with abacavir/dolutegravir/lamivudine remained suppressed with monthly injected cabotegravir and rilpivirine that was comparable in HIV viral suppression to continuation of abacavir/dolutegravir/lamivudine.
In a Phase II trial, patients treated with remimazolam for endoscopy sedation showed a success rate of 32%, 56%, and 64% for the low, medium and high dose groups of remimazolam compared to the 44% success rate with midazolam. A Phase IIb trial found a 92% success rate with remimazolam and 75% success rate with midazolam in sedation for colonoscopy. In a Phase III trial, successful sedation for colonoscopy was achieved in 91% of patients with remimazolam, 25% with midazolam and 2% with placebo. In a 446-patient trial, successful sedation for bronchoscopy was achieved in 80% of patients with remimazolam, 33% with midazolam and 5% with placebo.
GSK announced topline results from a Phase III trial, where oral daprodustat was non-inferior to darbepoetin in raising mean hemoglobin levels during weeks 40 to 52 in dialysis-dependent patients with anemia associated with chronic kidney disease.
In a Phase II, open label trial, tremelimumab added to durvalumab did not improve the objective response rate compared to durvalumab in patients with recurrent or metastatic head and neck squamous cell carcinoma.
In a Phase IIb, dose ranging trial, vibegron decreased average daily micturitions and the number of urge incontinence episodes compared to placebo in patients with overactive bladder. The combination of vibegron and tolterodine extended release improved daily micturitions and the number of urge incontinence episodes compared to monotherapy with either agent.
Astellas announced that in a Phase III trial, 57.7% of patients treated with peficitinib 100mg achieved AR20, 74.5% with 150mg and 30.7% with placebo in rheumatoid arthritis patients with an inadequate response to at least one conventional DMARD.
A phase III trial is underway for high risk locally advanced cervical cancer (NCT02853604). Advaxis’ axalimogene filolisbac is being studied in phase II trials for metastatic anal cancer, metastatic cervical head and neck cancer (in combination with durvalumab) and metastatic cervical cancer. The FDA has placed a hold on a Phase I/II trial examining the effect of axalimogene filolisbac plus durvalumab for the treatment of HPV-associated cervical or head and neck cancers due to a death during the trial. Advaxis discontinued the Phase I/II HPV-associated cervical or head and neck cancers trial and canceled a Phase III H cervical cancer trial. Advaxis withdrew its MAA for axalimogene filolisbac.
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