US FDA approves Lantidra, a cellular therapy revolutionizing type 1 diabetes treatment

USA — The US Food and Drug Administration (FDA) has made a groundbreaking announcement, granting approval to Lantidra, a pioneering cellular therapy for type 1 diabetes (T1D).

Lantidra is a unique allogeneic pancreatic islet cellular therapy derived from deceased donor pancreatic cells. This approval marks a significant milestone as it becomes the first treatment of its kind to receive regulatory clearance.

The FDA approval specifically applies to adults with “brittle” T1D, a subset of T1D patients who struggle to achieve target glycated hemoglobin (average blood glucose levels) due to recurrent severe hypoglycemic episodes, despite rigorous diabetes management and education.

While T1D accounts for approximately 5%-10% of all diabetes cases, only a small proportion, around three in every 1,000 individuals with T1D, suffer from the challenging “brittle” form of the disease.

Standard-of-care (SOC) treatment for T1D typically entails lifelong management through daily or continuous insulin administration, coupled with regular blood glucose monitoring.

However, SOC has its limitations, including the occurrence of hypoglycemia and impaired hypoglycemia awareness.

Lantidra operates by replacing the body’s insulin-producing beta cells in the pancreas. This is achieved through the infusion of allogeneic islet beta cells that secrete insulin, administered via a single infusion into the hepatic (liver) portal vein.

Depending on the patient’s response to the initial dose, an additional infusion may be administered.

In clinical trials, Lantidra has demonstrated remarkable efficacy for certain T1D patients. For some individuals, the infused cells generate sufficient insulin production to eliminate the need for insulin injections or pumps.

Out of 30 patients evaluated in two open-label studies, 21 remained free of insulin injections for a year or longer after the initial infusion.

Impressively, 11 patients successfully managed one to five years without insulin, while another ten individuals achieved over five years without requiring an injection.

Even in cases where complete independence from insulin was not achieved, the therapy provided a more stable background insulin production, which led to better management of diabetes by reducing fluctuations in blood sugar levels.

While the results are promising, it is worth noting that adverse reactions have been observed with Lantidra.

Most patients experienced at least one serious adverse reaction to the treatment administered via the hepatic portal vein and the concurrent use of immunosuppressants.

In some instances, discontinuation of immunosuppressants resulted in the loss of islet cell function, rendering the treatment ineffective.

Despite the treatment’s potential, experts in islet and pancreas transplantation have voiced concerns regarding the approval process.

Advocates for the Islets for the US movement argue against the current regulations surrounding islet transplantation.

They contend that since the cells are derived from deceased donors, the FDA should categorize islet transplantation as an organ transplant rather than a drug, as other regulatory bodies already do.

These experts assert that the current regulations fail to confirm the final islet product’s sterility and potency, while the lengthy biologics license application process has hindered research in the field.

Nevertheless, advancements in the industry may render this argument obsolete. Novo Nordisk recently entered a collaboration with Aspect Biosystems in a significant US$75 million deal.

The partnership aims to develop 3D-printed beta cells, eliminating the need for donor-derived cells and potentially overcoming the concerns raised by transplantation experts.

As Lantidra secures FDA approval, it paves the way for a new era in T1D treatment. This cellular therapy holds immense promise in transforming the lives of “brittle” T1D patients, offering them improved glycemic control and the possibility of reducing their dependence on exogenous insulin.

With ongoing developments and evolving regulatory perspectives, the future of cellular therapies for T1D looks increasingly optimistic.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.