New Drugs Added to Knowledgebase
Last week we added 10 new drugs to the knowledgebase:
The FDA approved sutimlimab (Enjaymo, Sanofi), on 2/4/2022, to decrease the need for red blood cell transfusions due to hemolysis in cold agglutinin disease.
The FDA designated CardiAMP (autologous mesenchymal stem cells), a Breakthrough Therapy for the treatment of heart failure.
Harpreet Singha and Richard Pazdura, of the FDA’s Oncology Center of Excellence, published an editorial in Lancet Oncology describing how current submissions for new drugs developed in China are only including data from trials only conducted in China. They question whether the data represents a broad enough patient sample for the U.S. population. They recommend use of multiregional clinical trials, which have been used for more than 20 years, to evaluate an investigational drug submitted to the FDA.
Announced Research Updates
Pharming announced that in a 12-week, 31 patient, Phase II/III trial, treatment with leniolisib resulted in a reduction in lymphadenopathy lesions and an increase in B cells in patients with Activated pI3Kdelta syndrome (APDS).
Vanda announced that in a 12-week, Phase III trial, treatment with tradipitant did not decrease the daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary compared to placebo in patients with gastroparesis.
Published Research Updates
In the 16-week, 98 patient, Phase III, THUNDER trial, treatment with fevipiprant did not improve the nasal polyp score compared to placebo in asthma patients with chronic rhinosinusitis with nasal polyps.
In a 30-month, 201 patient, Phase IIb trial, 46% of patients treated with probiotic and peanut oral immunotherapy (PPOIT) and 51% of patients who received only peanut immunotherapy (OIT) achieved 8-week sustained responsiveness after 18 months of treatment compared to 5% with placebo in Australian pediatric patients with peanut allergy. There was no difference between patients that received PPOIT or OIT.
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