The FDA approved ozanimod (Zeposia, Bristol Myers Squibb) on 3/25/2020 for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. BMS announced it would delay the launch for an unspecified time due to the COVID-19 pandemic. Pricing will be announced shortly before launch.
The FDA accepted the NDA for bupivacaine hydrochloride collagen-matrix for the management of postsurgical pain after open inguinal hernia surgery and set a PDUFA date of 8/26/2020.
The FDA requested additional information on beta beglogene darolentivec manufacturing; therefore Bluebird has delayed submission of a BLA to mid-2021.
Announced Research Updates
VBL Therapeutics announced positive interim results from 60 patients enrolled in the 400 patient, Phase III OVAL trial, where treatment with ofranergene obadenovec plus paclitaxel demonstrated a 58% overall response rate in patients with platinum-resistant ovarian cancer.
Inovio announced 6-month interim results from 20 patients enrolled in an 88-week, Phase II trial, where treatment with VGX-3100 resulted in an overall decrease in the number of lesions in 15/20 patients with 10/20 demonstrating clearance of HPV-16/18 associated precancerous lesions in adults with precancerous anal dysplasia caused by HPV-16 and/or HPV-18.
MyoKardia announced that in the 16-week, 59 patient, Phase II MAVERICK-HCM trial, treatment with mavacamten resulted in a 53% reduction in serum NT-proBNP compared to 1% reduction with placebo in patients with symptomatic, non-obstructive hypertrophic cardiomyopathy.
Published Research Updates
In the Phase III, ARCTIC trial, tremelimumab added to durvalumab improved overall survival and progression-free survival in heavily pretreated patients with metastatic non-small cell lung cancer.
In a 15-week, 57 patient, Phase II trial, treatment with tavapadon reduced the MDS-UPDRS Part III score by 9.0 points compared to a 4.3 point decrease with placebo in patients with early-stage Parkinson's disease.
In a 70 patient trial, levosimendan was comparable to milrinone on myocardial function after pediatric cardiac surgery.
In the 146 patient, Phase IIb, open-label, FIGHT-202 trial, treatment with pemigatinib resulted in an overall response in 38/107 patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.
In the 371 patient, Phase III BRIGHTE trial, fostemsavir was added to a failing antiviral regimen in patients with resistant infections or intolerance to a regimen. After 8 days the HIV-1 RNA level was 0.79 log10 copies per milliliter in the fostemsavir group and 0.17 log10 copies in the placebo group. At 48 weeks 54% of randomized patients and 38% of non-randomized patients maintained virologic suppression (<40 c/mL).
In a 5,050 patient, Phase III VICTORIA trial, 35.5% of patients treated with vericiguat experienced the primary outcome (composite of death from cardiovascular causes or first hospitalization for heart failure) compared to 38.5% in the placebo group in patients with chronic heart failure and an ejection fraction of less than 45% that were receiving guideline-based medical therapy.
In the Phase III, BETonMACE trial, apabetalone added to standard of care did not reduce major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or stroke) compared to placebo in high-risk patients with type 2 diabetes, recent acute coronary syndrome, and low HDL cholesterol.
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