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Marlborough, Mass. and Kigali, Rwanda, October 17, 2024–(BUSINESS WIRE)–TheracosBio and BAMCO Africa, Inc. today announced that BRENZAVVY® (bexagliflozin), an FDA-approved oral sodium-glucose cotransporter, ) announced that they have partnered to provide the following. 2 (SGLT2) inhibitors for the treatment of type 2 diabetes for patients in sub-Saharan Africa. BAMCO is a pioneering healthcare company committed to providing access to innovative treatments for patients in sub-Saharan Africa. BAMCO was carefully selected by TheracosBio due to the companies’ shared mission, BAMCO’s strong leadership team and extensive experience in the region.
“TheracosBio’s mission is to bring effective treatments to patients who need them at affordable prices, and BAMCO is doing the same for patients in sub-Saharan Africa.” TheracosBio said Brian Connelly, CEO. “We are excited to work with BAMCO to provide local physicians and their patients access to BRENZAVVY, a cost-effective treatment for managing type 2 diabetes,” said Connelly. added.
“BAMCO’s mission is to ensure that all patients in sub-Saharan Africa enjoy the right to better, with fair and timely access to the latest innovative treatments that save and improve their lives. ” said Markus Gemuend, CEO of BAMCO Africa. He added: “We are partnering with TheracosBio to provide access to BRENZAVVY to patients with type 2 diabetes, a rapidly increasing health burden, and to launch this innovative treatment in sub-Saharan Africa. We’re excited to work with the medical community to make this happen.”
BRENZAVVY is available as a 20 mg oral tablet and can be taken once daily in the morning with or without food. BRENZAVVY treatment can be initiated in adults with type 2 diabetes who have an estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m2 or higher. Patients with an eGFR of 30 to 59 mL/min/1.73 m2 are said to have stage 3 chronic kidney disease. In a Phase 3 clinical trial, BRENZAVVY significantly lowered hemoglobin A1c and fasting blood glucose levels after 24 weeks as monotherapy, in combination with metformin, or as an addition to standard treatment, which consisted of a variety of regimens, including: This has been shown. Metformin, sulfonylureas, insulin, DPP4 inhibitors, or a combination of these drugs. Although BRENZAVVY is not approved for weight loss or blood pressure reduction, modest reductions in both weight and blood pressure have been observed in clinical programs.
For more information about BRENZAVVY, please visit https://www.brenzavvy.com.
For more information about TheracosBio, please visit https://theracosbio.com.
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For more information about BAMCO, please visit https://bamcoafrica.com.
Indications and safety overview including warnings
BRENZAVVY is not recommended for use in patients with type 1 diabetes to improve glycemic control.
BRENZAVVY is contraindicated in patients with hypersensitivity to bexagliflozin or other components of BRENZAVVY tablets. The most common side effects of taking BRENZAVVY include female genital fungal infections, urinary tract infections, and changes in urination, but more serious side effects may also occur (see below).
For complete prescribing information for BRENZAVVY, please visit https://www.brenzavvy.com. To report suspected side effects, contact TheracosBio at 1-855-BRENZAVVY (1-855-273-6928) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Important safety information about BRENZAVVY
Limitations of Use: BRENZAVVY (Bexagliflozin) is not recommended for use in patients with type 1 diabetes to improve glycemic control. These patients may be at increased risk of diabetic ketoacidosis.
contraindication
BRENZAVVY is contraindicated in patients with hypersensitivity to bexagliflozin or BRENZAVVY excipients. Anaphylaxis and angioedema have been reported with sodium-glucose cotransporter 2 (SGLT2) inhibitors.
Warnings and precautions
Diabetic ketoacidosis in patients with type 1 diabetes and other ketoacidosis
BRENZAVVY increases the risk of life-threatening ketoacidosis in patients with type 1 diabetes. Type 2 diabetes and pancreatic disease are also risk factors for ketoacidosis, and fatal events of ketoacidosis have been reported in patients with type 2 diabetes using SGLT2 inhibitors. Diabetic ketoacidosis or other conditions that induce ketoacidosis include insufficient insulin administration due to reduced or missed insulin doses, acute febrile illness, decreased caloric intake, ketogenic diet, surgery, or These include decline, and alcohol abuse. Signs and symptoms of diabetic ketoacidosis are consistent with dehydration and severe metabolic acidosis and include nausea, vomiting, abdominal pain, general malaise, and shortness of breath. Evaluate patients who exhibit signs and symptoms of metabolic ketoacidosis regardless of blood glucose levels. If in doubt, discontinue BRENZAVVY, treat promptly and monitor recovery before restarting. Consider ketone monitoring in patients with type 1 diabetes as well as other patients at risk for ketoacidosis. Withhold BRENZAVVY in clinical situations known to predispose to ketoacidosis and resume once clinically stable. Educate all patients about the signs and symptoms of ketoacidosis and instruct patients to discontinue Blenzabuvy and seek immediate medical attention if signs or symptoms occur.
Lower limb amputation
In a study of type 2 diabetic patients with or at risk for cardiovascular disease (CVD), lower extremity amputations have been observed in patients treated with BRENZAVVY. Of the 23 amputees treated with BRENZAVVY, 15 had toe and midfoot amputations, and 8 had amputations above and below the knee. Some patients had multiple amputations. Lower extremity infections, gangrene, ischemia, and osteomyelitis were the most common medical events leading to the need for amputation. The risk of amputation was highest in patients with a baseline history of previous amputation, peripheral vascular disease, and neuropathy.
Before starting BRENZAVVY, consider factors in the patient’s medical history that may predispose to the need for amputation, such as past amputation history, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Counsel patients receiving BRENZAVVY about the importance of regular preventive foot care and avoid any signs and symptoms of diabetic foot infections (including osteomyelitis), new pain or tenderness, sores, or ulcers in the lower extremities. Monitor for symptoms and initiate appropriate treatment.
decrease in volume
BRENZAVVY can cause intravascular volume contraction, which may manifest as symptomatic hypotension and acute transient changes in creatinine. Acute kidney injury requiring hospitalization and dialysis has been reported in type 2 diabetic patients receiving SGLT2 inhibitors. Before starting, assess the volume status and renal status of patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, patients with low systolic blood pressure, or patients using loop diuretics. Evaluate functionality. For patients with volume loss, correct this condition. Once initiated, monitor for signs and symptoms of volume loss and renal function.
Urinary sepsis and pyelonephritis
Serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization, have been observed in patients receiving SGLT2 inhibitors, such as BRENZAVVY. Treatment with BRENZAVVY increases the risk of urinary tract infections. Assess patients for signs and symptoms of urinary tract infection and treat promptly.
Hypoglycemia due to combination with insulin and insulin secretagogues
Insulin and insulin secretagogues (such as sulfonylureas) are known to cause hypoglycemia. Using BRENZAVVY in combination with insulin and/or insulin secretagogues may increase the risk of hypoglycemia. When used with BRENZAVVY, the dose of insulin or insulin secretagogues may need to be reduced to minimize the risk of hypoglycemia.
Necrotizing fasciitis of the perineum (Fournier’s gangrene)
Post-marketing surveillance of diabetic men and women receiving SGLT2 inhibitors has identified serious and life-threatening cases requiring urgent surgical intervention. Serious consequences include hospitalization, multiple surgeries, and death. Evaluate patients who present with pain, tenderness, erythema, or swelling of the genitals or perineum along with fever and malaise. If in doubt, initiate treatment and discontinue BRENZAVVY.
Genital fungal infection
BRENZAVVY increases the risk of genital fungal infections. Patients who have a history of genital fungal infections or who have not been circumcised are more likely to develop genital fungal infections. Monitor and treat appropriately.
Most common side effects (>5%): female genital fungal infections, urinary tract infections, and increased urination.
Use in specific populations
Pregnancy: BRENZAVVY is not recommended during the second and third trimesters of pregnancy.
Breastfeeding: BRENZAVVY is not recommended for use while breastfeeding.
Elderly patients: Higher incidence of side effects related to volume loss.
Kidney Impairment: There is a higher incidence of side effects related to decreased kidney function.
Hepatic impairment: BRENZAVVY is not recommended for patients with severe hepatic impairment.
Drug interactions:
Inducers of UGT1A9 may result in more rapid metabolic clearance of BRENZAVVY. To offset the effects of BRENZAVVY, doses of insulin and sulfonylurea may need to be reduced. BRENZAVVY is unsafe when used with insulin or insulin secretagogues (sulfonylureas and meglitinides, the latter of which is rarely used in the United States). Lithium carbonate is used as a mood stabilizer for bipolar disorder. Lithium ions may be preferentially taken up along with glucose (compared to sodium ions) in the kidneys. Empirical evidence indicates that lithium levels may decrease when SGLT2 inhibitors are administered. SGLT2 inhibitors cause significant glycemia, rendering urine glucose testing diagnostically useless. Measurements of 1,5-anhydroglucitol are also impaired.
For other important safety information about BRENZAVVY, please see the complete prescribing information.
About Cerakos Bio
Founded in 2000, TheracosBio develops new, affordable treatments for diseases that have a significant impact on society. TheracosBio’s mission is to expand access to new medicines for patients with common diseases.
About Banco
Since its founding in 2023, BAMCO Africa has prioritized oncology and cardiometabolic diseases, working closely with governments and other partners in sub-Saharan Africa. We work collaboratively to address the unique challenges of healthcare, co-create sustainable solutions and implement them for the long-term benefit of society and patients. BAMCO Africa’s mission is to make standard-of-care medicines affordable and available in sub-Saharan Africa through partnerships, medical education, and clinical research.
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contact address
Cerakos media contact:
Irene Muloni
irene@mulonni.com
858-859-7001
BAMCO media contact:
Markus Gemund
markus@bamcoafrica.com
