The FDA approved Salix/Cosmo Pharmaceuticals’ rifamycin (Aemcolo), on 11/17/18 for the treatment of adults with travelers’ diarrhea. The drug had FDA Qualified Infectious Disease Product and Fast Track priority designations.
Jazz submitted an MAA for solriamfetol in November 2018.
In a Phase II trial, NGM’s FGF19 Biosynthetic ngm282 did not change alkaline phosphatase compared to placebo in patients with Primary Sclerosing Cholangitis. Secondary endpoints suggested a decrease in fibrosis biomarkers. The drug has Orphan Drug and Fast Track priority designations but no PDUFA Date.
Mesoblast’s rexlemestrocel-L (MPC-06-ID) is being developed for the treatment of chronic low back pain (CLBP) due to disc degeneration. The FDA has granted rexlemestrocel-L an Orphan Drug priority designation.
Lilly filed an NDA for lasmiditan in November 2018. See yesterday’s Migraine update for more details about this ditan. https://www.prescriberight.com/pipeline-news/new-drugs-in-development-for-the-treatment-of-acute-migraines
BioCardia announced preliminary 12-month results from the first 10 patients in the Phase III CardiAMP-HF Trial. These patients, who had experienced heart failure following a myocardial infarction, demonstrated a non-significant improvement in their Six Minute Walk Distance.
Merck’s Ebola vaccine was developed by the Canadian Public Health Agency. The vaccine is licensed to NewLink Genetics, which partnered with Merck for promotion and sales. The vaccine is being used in a 2018 Ebola outbreak in the Democratic Republic of the Congo. Merck initiated a rolling NDA in November 2018 and plans to complete the filing in 2019.
In a Phase II trial, 32.6% of patients treated with Aurinia Pharmaceuticals’ voclosporin 23.7 mg and 27.3% of patients treated with voclosporin 39.5 mg achieved complete renal remission (CRR) compared to 19.3% with placebo in lupus nephritis patients treated with mycophenolate mofetil and rapidly tapered low-dose oral corticosteroids. At 48 weeks, CRR was significantly greater with low-dose voclosporin compared to placebo.
An analysis by WHO cautioned of an increased risk for severe dengue in seronegative vaccine recipients compared to seronegative non-vaccinated patients with Sanofi's dengue vaccine, but long-term protection in seropositive individuals is achieved.
An 18-patient, Phase II trial suggested that prostate-specific membrane antigen (PSMA) positron emission tomography (PET) may predict treatment response of Lu-PSMA-617.
In a 292 patient, phase IIb trial, Johnson & Johnson (Janssen)’s pimodivir decreased the influenza viral load with or without osteltamivir and there was a non-significant trend in symptom improvement with the two drugs combined compared to placebo. Primodivir monotherapy resolved symptoms similar to osteltamivir or the combination of the two. FDA granted Fast Track priority to primodivir.
Chugai Pharma/Genentech’s emicizumab reduced the number of bleeds by 87% compared to on-demand bypassing agents in the 109 hemophilia A patient, phase III HAVEN-1 trial. 63% of emicizumab patients had no bleeds over 31 weeks compared to 6% that received bypassing agents. The company also revealed that interim results from the phase III Haven-2 pediatric trial suggested similar results in children. In the HAVEN-1 trial, prophylaxis with emicizumab was associated with improvements in hemophilia patient health-related outcomes (Haem-A-QoL, Haemo-QoL SF, IUS, EQ-VAS). The drug’s PDUFA Date is February 23, 2019 and it has a Breakthrough Therapy priority designation.
In a 28-day, 38 patient, Phase II trial, treatment with Novartis/Conatus’ emricasan decreased ALT, cCK18, flCK18 and caspase compared to placebo in patients with non-alcoholic fatty liver disease. The FDA granted emricasan Orphan Drug and Fast Track priority designations.
CytoDyn announced viral suppression responder rates for patients treated with various doses of weekly subcutaneous leronlimab as monotherapy for at least 12 weeks as 44% with 350 mg, 71% with 525 mg and 92% with 700 mg in patients with HIV.
The brand name for RedHill Biopharma’s ABC294640 is Yeliva and the generic name is opaganib. The drug targets refractory or relapsed multiple myeloma and has an Orphan Drug priority designation.
AZ announced that in the phase III MYSTIC trial, tremelimumab plus durvalumab did not improve progression free survival compared to a platinum-based regimen in treating NSCLC. Tremelimumab has an Orphan Drug priority designation.
CHMP has recommended approval of fexinidazole.
United Therapeutics licensed marketing rights to ralinepag, from Arena Pharmaceuticals in November 2018.
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