FDA approves Bydureon for use in T2D patients

AstraZeneca announces FDA approval of Bydureon for use in T2D patients

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FDA approves Bydureon for use in T2D patients

 

AstraZeneca (AZN) announced the FDA has approved BYDUREON for injectable suspension as an add-on therapy to basal insulin in adults with type 2 diabetes with inadequate glycemic control.

 

BYDUREON is approved for adults with T2D whose blood sugar remains uncontrolled on one or more antidiabetic medicines in addition to diet and exercise, to improve glycemic control.

 

The expanded use is based on results from the 28-week DURATION-7 study, which examined the effect of BYDUREON or placebo as add-on therapy to insulin glargine, with or without metformin, in adults with T2D.

 

Mean HbA1c was reduced by 0.9% in the BYDUREON group compared to 0.2% in the placebo group in patients with a mean baseline HbA1c of 8.5%.

 

Furthermore, 32.5% of patients in the BYDUREON group reached an HbA1c of less than 7.0% compared to 7.0% of patients in the placebo group.

 

There were no new safety findings in the DURATION-7 study.

 

Overall hypoglycemia was similar between the groups, with no reported major hypoglycemia.

 

In both arms, the same percentage of patients reported minor hypoglycemia. Like other GLP-1 receptor agonists, the risk of hypoglycemia is increased when BYDUREON is co-administered with insulin. Prescribers should consider lowering the dose of insulin when co-administering BYDUREON.


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Bio-Path says prexigebersen plus LDAC shows anti-leukemic activity

Prexigebersen plus LDAC shows early anti-leukemic activity

Prexigebersen plus LDAC shows early anti-leukemic activity. Stockwinners
Prexigebersen plus LDAC shows early anti-leukemic activity.

Bio-Path Holdings (BPTH) announces that interim data from its Phase 2 study of prexigebersen in combination with low-dose cytarabine for the treatment of acute myeloid leukemia has demonstrated that the combination therapy continues to be well-tolerated and has shown early anti-leukemic activity in nearly 50% of evaluable AML patients including four patients with complete remission and four with stable disease to date in this study.

The open-label Phase 2 study is evaluating the efficacy and safety of prexigebersen in conjunction with LDAC, a therapeutic regimen well established in treatment of AML patients who cannot or elect not to be treated with more intensive chemotherapy.

The primary objective of the study is to determine whether the combination of prexigebersen and LDAC provides greater efficacy than what would be expected with LDAC alone in this de novo patient population.

The study had a pre-determined decision point at 19 evaluable patients in which the study would be terminated if less than 5 patients responded and the study would be expanded to 54 patients if five or more patients responded.

The interim analysis was performed on 17 evaluable patients instead of 19, since criteria to move to the next steps in the study had been met.

Of the 17 evaluable patients, there were four patients who achieved complete responses, one patient who achieved a morphologic leukemia free state, two patients who had significantly reduced bone marrow blasts and four patients with stable disease.

In total, 47% of the evaluable patients showed some form of response, including stable disease, to the combination treatment.

The average age of patients in the study was 73.5 years old.

Based on the recommendations of the principal investigators of the study, the company is amending the protocol to change the dosing schedule to that used in the Phase 1b study in relapsed and refractory AML patients in which a higher dose of prexigerbesen was administered prior to LDAC treatment starting at day 10 versus LDAC treatment starting on day four as was the case in the BP1001-201 study to date.

In addition, the investigators endorse the inclusion of a decitabine cohort based on relatively new and positive data with this compound.

BPTH closed at $1.77, it last traded at $2.96


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