Pharma Fridays – March 8, 2024

An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *

Sandoz Receives FDA Approval for Denosumab Biosimilars

On March 5, Sandoz announced that the U.S. Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. 

Keren Haruvi, President Sandoz North America, said: “Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients. I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most.” 

Wyost® is approved to prevent skeletal-related events (SREs) in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. 

Bone is the third most frequent site for metastatic tumors. Nearly all types of cancer can spread to the bone and cause pain and fractures, though cancers that often metastasize in bones include breast and prostate. 

Jubbonti® is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

The FDA approval is based on robust clinical studies and accompanied by labeling with safety warnings. The Jubbonti® approval is also accompanied by approval of Sandoz’s Jubbonti® Risk Evaluation and Mitigation Strategy (REMS) program, which is designed to inform prescribers and patients about the risk of severe hypocalcemia associated with Jubbonti® in patients with advanced chronic kidney disease, including dialysis-dependent patients. 

Wyost® and Jubbonti® have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines. Wyost® and Jubbonti® are approved as interchangeable with the reference medicines for all indications. 

Given ongoing patent litigation around these products, Sandoz will not comment on anticipated launch timing or other launch details at this time. 

FDA Clears First Over-the-Counter Continuous Glucose Monitor

On March 5, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM).

The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition. 

“CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients.”

Stelo will be the first glucose biosensor in the U.S. cleared for use without a prescription.

The Stelo Glucose Biosensor System uses a wearable sensor, paired with an application installed on a user’s smartphone or other smart device, to continuously measure, record, analyze and display glucose values in people 18 years and older that are not on insulin and who do not have problematic hypoglycemia. Users can wear each sensor up to 15 days before replacing with a new sensor. The device presents blood glucose measurements and trends every 15 minutes in the accompanying app. Users should not make medical decisions based on the device’s output without talking to their healthcare provider. 

Data from a clinical study provided to the FDA showed that the device performed similarly to other iCGMs. Adverse events reported in the study included local infection, skin irritation and pain or discomfort.

As part of the Center for Devices and Radiological Health’s strategic priority to advance health equity, CDRH will continue to support innovation that addresses health equity by moving care and wellness into the home setting.

FDA Grants Orphan Drug Designation for Kidney Transplant Therapy

On March 6, Creative Medical Technology Holdings, Inc., received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for CELZ-101, ImmCelzTM.

This cutting-edge therapy is aimed at preventing allograft rejection in patients undergoing pancreatic islet cell transplantation, a significant advancement for individuals dealing with brittle type 1 diabetes. Creative Medical Holdings, Inc., is a leader in the field of regenerative medicine with a focus on developing novel therapies in immunotherapy, endocrinology, urology, gynecology, and orthopedics.

CELZ-101, also known as Supercharged Treg Biologic Immunotherapy (ImmCelzTM), represents a state-of-the-art approach in personalized medicine, utilizing the patient’s own regulatory T cells (Tregs) to combat autoimmune and alloimmune responses that can destroy insulin-producing cells. This innovative therapy is based on a proprietary process that not only expands Tregs but also enhances their functionality, offering a promising solution to reduce the need for lifelong immunosuppression.

Courtney Bartlett, DNP, AGACNP-BC, CCRP, Director of Clinical Development, commented, “The development of CELZ-101 is a major step forward in the realm of cell-based immunotherapy. It addresses the critical need for more effective treatments in brittle type 1 diabetes by aiming for operational tolerance in islet cell transplantation, potentially freeing patients from the burden of lifelong immunosuppression. We believe this is the first orphan designated, synergistic cell-based immunotherapy for brittle type 1 diabetes.”

“The Orphan Drug Designation by the FDA highlights CELZ-101’s potential to meet a significant unmet need in the prevention of allograft rejection during pancreatic islet cell transplantation which was recently approved by the FDA. This designation provides multiple important benefits to support the therapy’s development including tax advantages, user fee exemptions, and the opportunity for market exclusivity following approval,” added Timothy Warbington, CEO of the Company.

Creative Medical Technology Holdings, Inc., is dedicated to progressing CELZ-101 through the necessary regulatory pathways, with the goal of transforming the therapeutic landscape for patients in need of islet transplantation. This achievement underscores the company’s dedication to leveraging the natural regenerative capabilities of the human body to create lasting health solutions.

FDA Authorizes Type 1 Diabetes Preventative Therapy

On March 7, Creative Medical Technology Holdings, Inc., announced that the FDA has approved authorization for an expanded access therapy using CELZ-201, a pioneering cell-based program in managing abnormal glucose tolerance and preventing type 1 diabetes in high-risk individuals.

This therapy uses CELZ-201 to potentially prevent type 1 diabetes onset and is believed to be a first in medical history. This personalized medicine approach, focusing on a single high-risk patient, demonstrates the company’s dedication to innovative, tailored healthcare solutions.

CELZ-201 has a multi-target mechanism to address abnormal glucose tolerance, a type 1 diabetes precursor, at the cellular level. It embodies hope for high-risk individuals, offering a proactive defense against developing type 1 diabetes. This aligns with the company’s ethos of addressing diseases before they manifest, leveraging cutting-edge science for preventative care.

*Inclusion in Pharma Fridays does not suggest an endorsement by Endocrine News or the Endocrine Society.

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