March 17th, 2020
The FDA accepted the NDA for Athenex/Almirall’s tirbanibulin for the treatment of actinic keratosis and set a PDUFA date of 12/30/2020.
The FDA designated F2G’s olorofim as an Orphan Drug for the treatment of invasive aspergillosis and lomentospora/scedosporium infections.
Announced Research Updates
ORMD announced that in a 12-week, 269 patient, Phase IIb dose-ranging trial, treatment with oral insulin reduced HbA1c by 0.6% with 32 mg once daily and twice daily compared to placebo in patients with type 2 diabetes receiving metformin with up to two additional oral antihyperglycemic agents. Giving the dose three times per day did not improve HbA1c more than placebo.
AZ announced that in a Phase III, open-label trial, treatment with cediranib plus olaparib did not improve progression-free survival compared to platinum-based chemotherapy in patients with platinum-sensitive relapsed ovarian cancer.
Published Research Updates
In the 48-week, 877 patient, Phase III, STELLAR-4 trial, treatment with selonsertib 18 mg or 6 mg did not improve liver fibrosis by one stage or more without disease worsening compared to placebo (10-12% vs 13%) in patients with compensated cirrhosis due to NASH. In the 48-week, 803 patient, Phase III, STELLAR-3 trial, treatment with selonsertib 18 mg or 6 mg did not improve liver fibrosis by one stage or more without disease worsening compared to placebo (13-14% vs 13%) in patients with stage 3 fibrosis from NASH.
In the 14-week, 610 patient, Phase III, open-label, SUMMIT-07 trial, loxicodegol exhibited a low rate and severity of opioid withdrawal compared to placebo as measured by Clinical Opiate Withdrawal Scale (COWS) - 2.3% vs .05%; Subjective Opiate Withdrawal Scale (SOWS) - no difference; Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS) - 2.9% vs 3.7% in patients with chronic low back pain.
In a 48-week, 40 patient, Phase II trial, patients with chronic HBV who tested HBV e-antigen negative were treated for 48 weeks with tenofovir disoproxil fumarate, pegylated interferon alfa-2a and either REP 2139 or REP 2165. The two investigational drugs were equivalent in efficacy. At 48 weeks HBsAg levels were 0.05 IU/mL or lower in 24/40 patients. 48 weeks after the end of treatment virologic control persisted in 13/40 participants.
In a 115 patient, Phase II trial, trebananib plus bevacizumab had a worse 6-month PFS compared to bevacizumab monotherapy in patients with recurrent glioblastoma.
In a 234 patient, Phase II trial, treatment with olanzapine plus samidorphan did not reduce the time to the first event of exacerbation of disease symptoms compared to olanzapine monotherapy in patients with schizophrenia and alcohol use disorder.
A 22.7 month interim analysis of data from 843 patients participating in a Phase III, extension, open-label trial, showed that treatment with peficitinib resulted in ACR20/50/70 in 78.9%, 61.4%, and 42.7% of Asian patients with rheumatoid arthritis.
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