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Pipeline News and Updates
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Update for October 26, 2021

10/25/2021

 
National Pharmacy Week: October 17–23, 2021

National Pharmacy Week acknowledges the invaluable contributions pharmacists and technicians make to patient care in hospitals, outpatient clinics, and other healthcare settings.

Celebrated the third full week in October, “Pharmacy Week” is a time to recognize the powerful impact you make on your patients. It is an opportunity to raise your patients’ and colleagues’ awareness about the vital role pharmacists play on the healthcare team. It also provides a meaningful way for you to affirm your staff's hard work to ensure medication use at your organization is safe and patients are achieving optimal outcomes.

Regulatory Update

 
The FDA rejected elamipretide for the treatment of Barth syndrome and requested a well-controlled trial. The FDA found that in the Phase II trial submitted for approval, the blinded portion was negative, and the positive open-label extension was not adequately controlled to determine efficacy.
 
Announced Research Updates
 
LEO Pharma announced results from the initial 16-week treatment period of the 52-week, 289 patient, Phase III ECZTRA 6 trial, where 21.4% of patients treated with tralokinumab 150 mg and 17.5% that received 300 mg achieved an IGA score of 0 or 1 compared to 4.3% with placebo in adolescents with moderate-to-severe atopic dermatitis who were candidates for systemic therapy. EASI-75 was achieved by 28.6% of patients who received tralokinumab 150 mg and 27.8% with 300 mg compared to 6.4% with placebo.
 
Erytech announced that in the 512 patient, Phase III, TRYbeCA-1 trial, adding eryaspase to gemcitabine and nabpaclitaxel did not improve overall survival compared to gemcitabine plus nabpaclitaxel alone in patients with metastatic pancreatic cancer
 
Published Research Updates
 
In the 52-week, 2,002 patient, open-label, Phase III, SURPASS-4 trial, treatment with tirzepatide reduced HbA1c by 2.43% with 10 mg and 2.58% with 15 mg compared to a 1.44% decrease with insulin glargine in type 2 diabetics, inadequately controlled with oral drugs, who were at increased risk for cardiovascular disease.

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