FDA approved first interoperable insulin pump, as well as the only FDA-approved drug for patients with a neglected tropical disease.
In the past week, FDA okayed a new type of insulin pump for diabetics as well as the only FDA-approved drug for people with fascioliasis (liver fluke infestation).
The t:Slim X2 insulin pump with interoperable technology (Tandem Diabetes Care Inc.) is the first alternate controller enabled (ACE) interoperable pump. It can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual device preferences, FDA said in a statement.
Diabetes therapy systems may be comprised of ACE insulin pump and other compatible medical devices, including automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters, or other electronic devices used for diabetes management.
“Diabetes is a complicated disease that requires close monitoring and carefully tailored treatments. We’ve heard from the patient community that having the ability to customize their own diabetes management devices is important to them. Advances in digital health make more tailored approaches to diabetes care possible,” said FDA Commissioner Scott Gottlieb, MD, in the statement.
The pump has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently, Gottlieb said. “Because the FDA’s action creates a new regulatory classification, future ACE insulin pumps will be able to go through the more efficient 510(k) review process, helping to advance this innovative technology.”
In other FDA news, the agency cleared triclabendazole (Egaten, Novartis) to treat fascioliasis in patients aged 6 years and older. “This makes Egaten the only FDA-approved drug for people with this disease and is expected to facilitate broader access to this important drug not only in the US, but also in affected countries worldwide,” Novartis said in a statement.
"Today’s FDA approval of Egaten is another important milestone that we believe will help further expand access to this one-day treatment, taking us a step closer toward disease elimination," said Vas Narasimhan, CEO of Novartis, in the statement.
Fascioliasis, commonly known as liver fluke infestation, is a neglected tropical disease that infects 2.4 million people worldwide, with an additional 180 million at risk of infection. It is caused by 2 species of parasitic flatworms that can infect humans following ingestion of larvae in contaminated water or food.
Egaten is currently the only medicine for fascioliasis recommended by the WHO and is on the WHO Model List of Essential Medicines. It is supplied by WHO during epidemic outbreaks and for periodic use in endemic countries.
FDA’s approval of Egaten is expected to facilitate drug licensing and import to endemic countries, “helping ensure sufficient and prompt availability of the drug when needed,” Novartis said.
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